Lilly's triple agonist, retatrutide, delivered substantial weight loss and A1C reduction, underscoring its potential promise for people with obesity and type 2 diabetes

Lilly plans a Q1 2027 U.S. marketing application following the 80-week trial in adults with type 2 diabetes and obesity or overweight.

Rhea-AI Summary

Eli Lilly and Company (LLY) reported Phase 3 TRIUMPH-2 results showing retatrutide reduced weight in adults with type 2 diabetes and obesity or overweight. At 80 weeks, average weight loss was 12.7%, 19.1% and 20.8% with 4 mg, 9 mg and 12 mg, respectively, versus 4.0% with placebo. A1C, a measure of average blood sugar, fell 1.4%, 1.6% and 1.5%, respectively, versus 0.2% with placebo.

With 12 mg, 59.5% no longer met obesity BMI criteria; participants starting with BMI of 35 or higher lost an average of 60.8 lbs. Cardiovascular risk measures also improved. Adverse-event discontinuations were 3.8%, 11.6% and 7.7% across ascending doses, versus 4.9% with placebo. Results estimate efficacy assuming participants remained on treatment without prohibited weight-management treatments or, for blood-sugar endpoints, rescue therapy. Lilly plans to submit a U.S. marketing application in Q1 2027.

16 points · 1 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 10 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major point80-week weight loss averaged 12.7%, 19.1% and 20.8% at 4, 9 and 12 mg, versus 4.0% placebo.
• Moderate pointA1C reductions averaged 1.4%, 1.6% and 1.5% at ascending doses, versus 0.2% placebo, from 7.7% baseline.
• Moderate point. Forward-looking: it has not happened yet and may not happen.U.S. marketing application submission is planned by Lilly for Q1 2027.
• Minor pointA1C ≤6.5% reached by 73.1%, 79.2% and 79.0% at ascending doses, versus 26.3% placebo.
• Minor pointA1C reached by 28.4%, 40.0% and 39.3% at ascending doses, versus 4.4% placebo.

11 minor points

• Minor pointAt least 15% weight loss achieved by 36.6%, 62.2% and 67.0% at ascending doses, versus 6.4% placebo.
• Minor pointAt least 20% weight loss achieved by 24.0%, 45.3% and 52.0% at ascending doses, versus 1.5% placebo.
• Minor pointAt least 25% weight loss achieved by 10.8%, 30.6% and 34.9% at ascending doses, versus 0.8% placebo.
• Minor point59.5% taking 12 mg no longer met BMI criteria for obesity by study end.
• Minor point60.8 lbs average weight loss with 12 mg among participants starting with BMI of 35 or higher.
• Minor pointTriglycerides declined an average of 39.5% with the highest dose.
• Minor pointNon-HDL cholesterol declined an average of 19.6% with the highest dose.
• Minor pointSystolic blood pressure declined an average of 10.8 mmHg with the highest dose.
• Minor pointWaist circumference declined an average of 6.7 in (16.9 cm) with the highest dose.
• Minor pointHigh-sensitivity C-reactive protein, an inflammation marker, declined an average of 58.3% with the highest dose.
• Minor point. Forward-looking: it has not happened yet and may not happen.Additional Phase 3 results are anticipated by Lilly over the next year.

Negative

• Moderate pointAdverse-event discontinuations were 3.8%, 11.6% and 7.7% at ascending doses, versus 4.9% placebo.
• Minor pointDiarrhea occurred in 27.4%, 33.5% and 33.6% at ascending doses, versus 13.2% placebo.
• Minor pointNausea occurred in 13.7%, 20.8% and 28.0% at ascending doses, versus 8.0% placebo.
• Minor pointConstipation occurred in 14.0%, 16.2% and 16.8% at ascending doses, versus 9.4% placebo.
• Minor pointDecreased appetite occurred in 5.8%, 12.3% and 17.1% at ascending doses, versus 4.5% placebo.

5 minor points

• Minor pointVomiting occurred in 5.5%, 10.2% and 15.7% at ascending doses, versus 4.2% placebo.
• Minor pointDysesthesia, abnormal sensation, occurred in 4.5%, 5.6% and 7.3% at ascending doses, versus 0.7% placebo.
• Minor pointUrinary tract infections occurred in 3.8%, 6.3% and 8.0% at ascending doses, versus 6.6% placebo.
• Minor pointEfficacy estimates assume continued treatment without prohibited weight-management treatments or, for blood-sugar endpoints, rescue therapy.
• Minor pointA1C 5.7% endpoint/b was not statistically adjusted to control false-positive findings across multiple comparisons.

News Explained

Retatrutide remains investigational and cannot legally be sold or marketed; Lilly plans a U.S. BLA submission in Q1 2027, so these Phase 3 results do not make it currently available.

Key Figures

Body-weight change: −20.8% (−49.6 lbs) A1C reduction: −1.6% No longer meeting obesity BMI criteria: 59.5% +4 more

Body-weight change

−20.8% (−49.6 lbs)

Retatrutide 12 mg at 80 weeks; placebo −4.0%

A1C reduction

−1.6%

Retatrutide 9 mg at 80 weeks

No longer meeting obesity BMI criteria

59.5%

Participants taking retatrutide 12 mg by study end

Reached A1C below 5.7%

40.0%

Participants taking retatrutide 9 mg at 80 weeks

TRIUMPH-2 enrollment

1,152 participants

Phase 3 trial

Planned BLA submission

Q1 2027

Planned submission to the U.S. FDA

Discontinuation due to adverse events

11.6% at 9 mg; 4.9% with placebo

TRIUMPH-2

Key Terms

glp-1, gip

2 terms

glp-1 medical

"GIP, GLP-1, and glucagon triple hormone receptor agonist"

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

gip medical

"GIP, GLP-1, and glucagon triple hormone receptor agonist"

GIP commonly stands for Global Infrastructure Partners, a private investment firm that buys and manages large physical assets such as airports, power plants, toll roads and pipelines. Investors pay attention because when GIP acquires, invests in, or sells such assets it can alter cash flow, debt levels and long-term plans for those businesses—like a new landlord changing rents or making upgrades—affecting revenue, dividends and risk for shareholders and creditors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

09/29/2026 - 06:00 PM

In TRIUMPH-2, participants with obesity and type 2 diabetes taking retatrutide 12 mg lost an average of 49.6 lbs (20.8%) over 80 weeks, with more than half no longer meeting the BMI criteria for obesity

Participants with a baseline BMI of 35 or higher who took retatrutide 12 mg lost up to an average of 60.8 lbs (23.4%) of their body weight

Retatrutide reduced A1C by up to an average of 1.6%, with up to 40.0% reaching an A1C of <5.7%

INDIANAPOLIS, Sept. 29, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), today announced detailed results from TRIUMPH-2, a Phase 3 trial evaluating the efficacy and safety of retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist, in adults with type 2 diabetes and obesity or overweight. At 80 weeks, all doses of retatrutide (4 mg, 9 mg, and 12 mg) delivered substantial weight loss and reductions in A1C.¹ Results were presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan, Italy, and simultaneously published in The Lancet.

"The vast majority of people with type 2 diabetes are also living with obesity, and treating the two together has always been a challenge," said Juan P. Frías, M.D., Medical Director and Principal Investigator, Los Angeles Institute for Metabolic Research. "In TRIUMPH-2, retatrutide reduced both weight and blood sugar substantially, with more than half of participants no longer qualifying as having obesity and up to 40% reaching an A1C in the normal range. Results such as these may change what we set out to achieve with a single therapy for adults living with type 2 diabetes and obesity."

Participants taking retatrutide 4 mg, 9 mg, and 12 mg lost an average of 29.8 lbs (12.7%), 45.4 lbs (19.1%), and 49.6 lbs (20.8%), respectively. Among participants with a baseline BMI of 35 or higher, those taking retatrutide 12 mg lost an average of 60.8 lbs (23.4%). By the end of the study, 59.5% of participants taking retatrutide 12 mg no longer met the BMI criteria for obesity.

Beyond substantially reducing weight, retatrutide also helped participants better control their A1C. Participants taking retatrutide 9 mg and 12 mg reduced their A1C by an average of 1.6% and 1.5%, respectively, while those taking 4 mg reduced their A1C by an average of 1.4%. Notably, up to 40.0% of participants reached an A1C of <5.7%, which is considered a normal blood sugar level.

TRIUMPH-2 Efficacy Estimand Results2
Primary Endpoint at 80 Weeks
	Retatrutide 4 mg	Retatrutide 9 mg	Retatrutide 12 mg	Placebo
Percent change in body weight at 80 weeks from avg. baseline of 106.4 kg (234.6 lbs; BMI of 38.2 kg/m²)	-12.7%   (-13.5 kg; -29.8 lbs)i	-19.1%   (-20.6 kg; -45.4 lbs)	-20.8%   (-22.5 kg; -49.6 lbs)	-4.0%   (-4.2 kg; -9.3 lbs)
Secondary Endpoints at 80 Weeks
Change in A1C from an avg. baseline of 7.7%	-1.4 %	-1.6 %	-1.5 %	-0.2 %
Percent of participants achieving A1C ≤6.5%	73.1 %	79.2 %	79.0 %	26.3 %
Percent of participants achieving A1C <5.7%ii	28.4 %	40.0 %	39.3 %	4.4 %
Percent of participants achieving body weight reduction of ≥15%	36.6 %	62.2 %	67.0 %	6.4 %
Percent of participants achieving body weight reduction of ≥20%	24.0 %	45.3 %	52.0 %	1.5 %
Percent of participants achieving body weight reduction of ≥25%	10.8 %	30.6 %	34.9 %	0.8 %
iPercent body weight reduction with retatrutide 4 mg was a key secondary endpoint.
iiNot controlled for family-wise type 1 error.

Retatrutide also meaningfully reduced certain cardiovascular risk factors, with the highest dose delivering average reductions of 39.5% in triglycerides, 19.6% in non-HDL cholesterol, 10.8 mmHg in systolic blood pressure, 6.7 in (16.9 cm) in waist circumference, and 58.3% in high-sensitivity C-reactive protein (hsCRP).

"TRIUMPH-2 shows what the next generation of cardiometabolic medicine could deliver: substantial weight loss, A1C reduction and improvements across other critical cardiovascular risk factors," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "With efficacy this powerful and consistent across our Phase 3 program, we believe retatrutide could become an important option for people living with type 2 diabetes and obesity."

In TRIUMPH-2, the most common adverse events with retatrutide (4 mg, 9 mg, 12 mg vs. placebo, respectively) were diarrhea (27.4%, 33.5%, 33.6% vs. 13.2%), nausea (13.7%, 20.8%, 28.0% vs. 8.0%), constipation (14.0%, 16.2%, 16.8% vs. 9.4%), decreased appetite (5.8%, 12.3%, 17.1% vs. 4.5%), and vomiting (5.5%, 10.2%, 15.7% vs. 4.2%). Incidences of dysesthesia and urinary tract infections were 4.5%, 5.6%, 7.3% vs. 0.7% and 3.8%, 6.3%, 8.0% vs. 6.6% with retatrutide 4 mg, 9 mg, 12 mg vs. placebo, respectively. These events were generally mild to moderate, and the majority resolved during treatment. Discontinuation rates due to adverse events in TRIUMPH-2 were 3.8% (4 mg), 11.6% (9 mg), and 7.7% (12 mg) with retatrutide, compared with 4.9% for placebo.

Lilly plans to submit a Biologics License Application (BLA) in Q1 2027 to the U.S. Food and Drug Administration. Additional results from the obstructive sleep apnea trial within TRIUMPH-2 will be presented at a future medical meeting and published in a peer-reviewed journal.

About retatrutide
Retatrutide is an investigational, once-weekly, triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that cannot be legally sold or marketed for human use.

About TRIUMPH-2 and the TRIUMPH clinical trial program
TRIUMPH-2 (NCT05929079) is a Phase 3, 80-week, randomized, double-blind and placebo-controlled trial under a basket design investigating the efficacy and safety of retatrutide once weekly compared with placebo in participants with type 2 diabetes and obesity or overweight. TRIUMPH-2 included a master trial for obesity and type 2 diabetes and a basket trial for moderate-to-severe obstructive sleep apnea. The study randomized 1,152 participants in a 1:1:1:1 ratio to receive retatrutide 4 mg, 9 mg, 12 mg, or placebo. Participants randomized to retatrutide initiated treatment with 2 mg once weekly and increased the dose in a stepwise approach every four weeks until reaching the target dose of 4 mg (via a step at 2 mg), 9 mg (via steps at 2 mg, 4 mg, and 6 mg) or 12 mg (via steps at 2 mg, 4 mg, 6 mg, and 9 mg). TRIUMPH-2 included a post-treatment follow-up period of 4 weeks.

The initial TRIUMPH Phase 3 clinical development program is evaluating the safety and efficacy of retatrutide for the treatment of patients with obesity or overweight, type 2 diabetes, moderate-to-severe obstructive sleep apnea (OSA) and obesity and knee osteoarthritis pain across four global registrational trials. The program, which began in 2023, has enrolled more than 5,800 participants with additional results anticipated over the next year.

Endnotes

1. All data in this press release represent the efficacy estimand.
2. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 80 weeks without initiating prohibited weight management treatments (and glycemic rescue therapy for glycemic endpoints only).

U.S. FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

• Foundayo should not be used with other GLP-1 receptor agonist medicines. 
• It is not known if Foundayo is safe and effective for use in children. 

Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). 
• Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 
• Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. 

Foundayo may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking Foundayo

• Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. 
• Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). 
• If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. 
• Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. 

Review these questions with your healthcare provider:

❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?

How to take

• Take Foundayo exactly as your healthcare provider tells you to. 
• Use Foundayo with a reduced-calorie diet and increased physical activity. 
• Take Foundayo by mouth 1 time each day, with or without food. 
• Swallow tablets whole. Do not break, crush, or chew the tablet. 
• If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. 
• Do not take more than 1 tablet per day. 
• If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. 
• If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. 

Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026

Foundayo^™ is a trademark of Eli Lilly and Company.

U.S. ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound^® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:

• obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
• moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

KwikPen^®: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

• Your healthcare provider should show you how to use Zepbound before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:

❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

• Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may call 1-844-524-0039 or email at MILEregistry@thermofisher.com or visit https://pregnancyregistry.lilly.com/zepbound.

How to take

• Read the Instructions for Use that come with Zepbound.
• Use Zepbound exactly as your healthcare provider says.
• Use Zepbound with a reduced-calorie diet and increased physical activity.
• Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or
  have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
• Use Zepbound 1 time each week, at any time of the day.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.

If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 01SEP2026

Zepbound^®, its delivery device base and KwikPen^® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. 

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about retatrutide as a potential treatment for adults with type 2 diabetes, obesity and other indications, potential efficacy and tolerability of retatrutide, and the timeline for future readouts, presentations and other milestones relating to retatrutide and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with expectations or study results to date, that retatrutide will prove to be a safe and effective treatment for type 2 diabetes, obesity or other potential indications, that retatrutide will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Refer to:	Niki Biro; niki_biro@lilly.com (Media)
	Michael Czapar; czapar_michael_c@lilly.com (Investors)

 

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-delivered-substantial-weight-loss-and-a1c-reduction-underscoring-its-potential-promise-for-people-with-obesity-and-type-2-diabetes-302891798.html

SOURCE Eli Lilly and Company

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much weight did retatrutide reduce in Lilly's TRIUMPH-2 trial?

Average weight loss at 80 weeks was 12.7%, 19.1% and 20.8% with retatrutide 4 mg, 9 mg and 12 mg, respectively, versus 4.0% with placebo. These corresponded to 29.8 lbs, 45.4 lbs and 49.6 lbs, versus 9.3 lbs with placebo.

How much did retatrutide lower A1C in Lilly's TRIUMPH-2 trial?

From an average baseline of 7.7%, A1C fell 1.4%, 1.6% and 1.5% with retatrutide 4 mg, 9 mg and 12 mg, respectively, versus 0.2% with placebo. A1C measures average blood sugar.

How was Lilly's TRIUMPH-2 retatrutide trial designed?

TRIUMPH-2 was an 80-week, randomized, double-blind, placebo-controlled Phase 3 trial involving 1,152 participants. Participants were assigned equally to 4 mg, 9 mg, 12 mg or placebo. Retatrutide started at 2 mg once weekly, with stepwise increases every four weeks until the assigned dose was reached.

Were side effects in Lilly's TRIUMPH-2 retatrutide trial severe?

The reported adverse events were generally mild to moderate, and most resolved during treatment. The most common were diarrhea, nausea, constipation, decreased appetite and vomiting. Dysesthesia, or abnormal sensation, and urinary tract infections were also reported.

When will Lilly report TRIUMPH-2 retatrutide sleep apnea results?

Lilly plans to present additional results from the obstructive sleep apnea trial within TRIUMPH-2 at a future medical meeting and publish them in a peer-reviewed journal.