AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults

Rhea-AI Summary

AbbVie (NYSE: ABBV) announced positive topline Phase 1 multiple ascending dose results for ABBV-295 on March 9, 2026. ABBV-295, a long-acting amylin analog, produced dose-dependent mean weight reductions of -7.75% to -9.79% at week 12 (weekly dosing) and -7.86% to -9.73% at week 13 (alternate dosing), versus placebo ~-0.25%.

The study tested 2–14 mg doses, enrolled mostly male participants (88.3%), showed a favorable tolerability profile with no serious adverse events, and reported mostly mild gastrointestinal events early in treatment. Full data will be presented at a future scientific conference.

Positive

• Dose-dependent weight reductions up to -9.79% at week 12
• Placebo‑adjusted effect versus ~-0.25% placebo at weeks 12–13
• Favorable tolerability with no serious adverse events reported

Negative

• Study population mean BMI 30 kg/m2, limiting direct obesity population inference
• Enrollment skewed male at 88.3%, reducing generalizability to females
• Most common adverse events were gastrointestinal, occurring early in treatment

News Market Reaction – ABBV

-1.16%

1 alert

-1.16% News Effect

On the day this news was published, ABBV declined 1.16%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Weight change week 12: -7.75% to -9.79% Weight change week 13: -7.86% to -9.73% Placebo weight change: -0.26% and -0.25% +5 more

8 metrics

Weight change week 12 -7.75% to -9.79% LS mean body weight change, weekly ABBV-295 dosing, week 12

Weight change week 13 -7.86% to -9.73% LS mean body weight change, q2w/monthly ABBV-295 dosing, week 13

Placebo weight change -0.26% and -0.25% LS mean body weight change in placebo at weeks 12 and 13

BMI threshold <30 kg/m2 Mean body mass index of enrolled adults

Male enrollment 88.3% Proportion of male participants in Phase 1 MAD study

Dose range 2–14 mg ABBV-295 doses tested with various escalations and frequencies

Cohort 5a week 12 -9.79% (95% CI -11.99, -7.59) LS mean weight change, weekly dosing cohort 5a, week 12

Cohort 6 week 13 -7.86% (95% CI -9.80, -5.91) LS mean weight change, monthly dosing after week 5, week 13

Market Reality Check

Price: $219.68 Vol: Volume 4,266,321 is 0.64x...

low vol

$219.68 Last Close

Volume Volume 4,266,321 is 0.64x the 20-day average, indicating subdued activity pre-release. low

Technical Price 230.36 is trading above the 200-day MA at 213.54.

Peers on Argus

ABBV was down 0.96% while key peers JNJ, AZN, NVS and LLY were up between 0.24% ...

1 Up

ABBV was down 0.96% while key peers JNJ, AZN, NVS and LLY were up between 0.24% and 2.18%, and NVO was flat, pointing to a stock-specific setup.

Common Catalyst AZN news focused on oncology (ENHERTU Priority Review), distinct from ABBV’s obesity-focused amylin analog data.

Previous Clinical trial Reports

5 past events · Latest: Mar 02 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 02	Phase 3 Crohn’s data	Positive	+0.9%	SKYRIZI Phase 3 AFFIRM met co-primary endpoints with strong remission rates.
Jan 16	Phase 3 lymphoma data	Positive	-1.1%	Epcoritamab improved PFS in DLBCL but lacked statistically significant OS benefit.
Oct 29	Phase 3 vitiligo data	Positive	-1.1%	Upadacitinib met co-primary repigmentation endpoints in two Phase 3 vitiligo studies.
Oct 20	Head-to-head RA study	Positive	+1.1%	RINVOQ showed superiority to HUMIRA in RA after TNF inhibitor failure.
Oct 06	Phase 2 tremor study	Positive	-1.6%	BOTOX met primary and all secondary endpoints in essential tremor Phase 2 trial.

Pattern Detected

Across recent clinical trial announcements, ABBV often showed mixed reactions, with 3 divergence days versus 2 aligned moves.

Recent Company History

Over the past months, AbbVie has repeatedly reported positive clinical data across multiple programs, including Crohn’s disease with SKYRIZI, DLBCL with epcoritamab, vitiligo and rheumatoid arthritis with RINVOQ, and essential tremor with BOTOX. These events typically met key efficacy endpoints with safety consistent with known profiles. Market reactions were mixed, with both gains and declines despite positive topline messages. Today’s ABBV-295 Phase 1 MAD results add an early-stage obesity candidate with meaningful weight loss to this ongoing stream of pipeline updates.

Historical Comparison

-0.3% avg move · In the last five clinical trial updates, ABBV’s average 24-hour move was -0.35%, showing that even p...

clinical trial

-0.3%

Average Historical Move clinical trial

In the last five clinical trial updates, ABBV’s average 24-hour move was -0.35%, showing that even positive data have often met with cautious trading.

Historical same-tag events were mainly Phase 2–3 programs in immunology, oncology and neurology, whereas ABBV-295 represents earlier-stage Phase 1 obesity data, broadening AbbVie’s clinical footprint into metabolic disease.

Market Pulse Summary

This announcement highlights encouraging Phase 1 MAD results for ABBV-295, with ~8–10% least-squares...

Analysis

This announcement highlights encouraging Phase 1 MAD results for ABBV-295, with ~8–10% least-squares mean weight loss and a reported favorable tolerability profile versus minimal placebo change. Within AbbVie’s broader record of positive yet variably received clinical updates, ABBV-295 represents an early obesity-focused addition. Investors may track future dose-ranging, durability, and safety data, along with progression into later-stage trials, to better assess its role in AbbVie’s expanding pipeline.

Key Terms

amylin analog, pharmacokinetics, pharmacodynamics, body mass index, +4 more

8 terms

amylin analog medical

"ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class"

An amylin analog is a man-made version of the natural hormone amylin that helps control blood sugar and suppress appetite; it acts like a substitute key that fits the same locks in the body to slow stomach emptying and reduce spikes after meals. Investors watch these drugs because clinical trial results, regulatory approval, safety and manufacturing scale determine their market potential in diabetes and weight-management treatments, affecting revenue and competitive positioning.

pharmacokinetics medical

"evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

body mass index medical

"adults with a mean body mass index (BMI) of less than 30 kg/m2"

Body mass index (BMI) is a simple number calculated from a person’s weight and height that gives a rough measure of whether their body size is underweight, normal, overweight, or obese, similar to using a single score to gauge whether a container is underfilled or overfilled. Investors care because average BMI trends affect demand and costs in healthcare, insurance, and consumer markets, and can signal population health risks that influence long-term revenues and liabilities.

least-squares mean technical

"clinically meaningful body weight reduction from -7.75% to -9.79% (least-squares mean)"

An adjusted average calculated from a statistical model that estimates what a group’s typical outcome would be after accounting for other influencing factors (like age, baseline status, or different study conditions). Investors use it to compare results more fairly—for example, to judge a drug’s effect or a strategy’s performance while removing imbalances—so it helps assess true effect sizes that can affect clinical, regulatory, and valuation decisions.

mixed model for repeated measures technical

"LS mean estimates were derived using a Mixed Model for Repeated Measures (MMRM)."

A mixed model for repeated measures is a statistical method used in clinical trials to compare how groups change over time while using each participant’s own earlier results as part of the analysis. Think of it like comparing students’ test-score trends where missing exams are common: the method borrows information across visits to produce more reliable estimates of a treatment’s effect. Investors care because these analyses influence whether trial results look convincing to regulators and the market, affecting approvals, forecasts, and stock value.

subcutaneous medical

"pharmacodynamics (PD) of subcutaneous ABBV-295, in adults"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

placebo medical

"compared to -0.26% and -0.25% in the placebo group at week 12 and week 13"

A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.

AI-generated analysis. Not financial advice.

• ABBV-295 treatment showed clinically meaningful body weight reduction from -7.75% to -9.79% (least-squares mean) at week 12 (weekly dosing), to -7.86% to -9.73% at week 13 (every other week and monthly dosing after week 5)¹
• ABBV-295 demonstrated a favorable tolerability profile at all evaluated dose levels.  No serious adverse events were reported¹
• Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action

NORTH CHICAGO, Ill., March 9, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results¹ from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m². ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.  

Study enrollment mostly comprised male participants (88.3%). Different doses (2-14 mg), titrations and dose frequencies were tested in the study. ABBV-295 was generally well tolerated across all dose levels evaluated. The most commonly reported adverse events were gastrointestinal disorders, which were mostly mild, and predominantly occurred during the first 6 weeks of treatment.¹

ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week 5), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.¹ 

"Obesity is a complex, chronic disease that places a substantial burden on patients, healthcare systems and society, and there remains a critical need for therapies that combine efficacy with tolerability and support long-term adherence," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile. These initial results further reinforce the potential of ABBV-295 as a novel therapeutic option for people living with obesity."

Results from the single ascending doses (SAD) part and other cohorts from the MAD part of the study were announced previously. Full data from the study will be presented at a future scientific conference.

Summary of Phase 1 MAD Study Key Results¹ (Percent Change from Baseline in Body Weight at Week 12 and Week 13)

Cohorta	LS Mean (95% CI) at week 12b	LS Mean (95% CI) at week 13b
All Placebo	-0.26 (-1.89, 1.37)	-0.25 (-1.88, 1.38)
Cohort 3 (weekly dosing)	-7.75 (-9.89, -5.61)	-
Cohort 4 (weekly dosing)	-8.70 (-10.75, -6.65)	-
Cohort 5a (weekly dosing)	-9.79 (-11.99, -7.59)	-
Cohort 5b (every other week dosing)	-7.76 (-9.82, -5.70)	-9.73 (-11.79, -7.67)
Cohort 6 (monthly dosing after week 5)	-6.74 (-8.70, -4.79)	-7.86 (-9.80, -5.91)

a Doses from 2mg to 14mg were tested using different dose escalations and dosing frequencies.

b LS mean estimates were derived using a Mixed Model for Repeated Measures (MMRM). Participants were required to adhere to the dosing plan and those unable to continue treatment were withdrawn from the study with no further efficacy data collected.

About ABBV-295
ABBV-295 is an investigational, long-acting amylin analog being developed for the treatment of obesity. It is an agonist that specifically activates amylin and calcitonin receptors. Amylin, a satiety hormone, has been identified as a potential therapeutic target for the treatment of obesity given its role in activating signals to the brain that result in appetite suppression and the reduction of food intake, while also acting as an inhibitory signal to delay gastric emptying. ABBV-295 has not been approved by any health regulatory authority worldwide. The safety and efficacy of ABBV-295 have not been established.

About the Phase 1 GUC17-01 Study
The Phase 1 clinical trial is a two-part, single center, double-blind (within cohorts), randomized, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study of subcutaneous ABBV-295 (GUB014295). A total of 76 participants were enrolled in the MAD study. More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT06144684). 

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

 References:

1. AbbVie Data on File: ABVRRTI82837
2. A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06144684?intr=GUB014295&rank=1#participation-criteria.  Accessed March 3, 2026.

Contacts:

Media:	Investors:
Sourojit (Jit) Bhowmick, Ph.D.	Liz Shea
jit.bhowmick@abbvie.com	liz.shea@abbvie.com

View original content:https://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-a-phase-1-multiple-ascending-dose-study-of-abbv-295-a-long-acting-amylin-analog-in-adults-302707602.html

SOURCE AbbVie

FAQ

What were the key Phase 1 results for ABBV-295 announced March 9, 2026 (NYSE: ABBV)?

ABBV-295 produced dose-dependent weight loss of -7.75% to -9.79% at week 12 and -7.86% to -9.73% at week 13. According to the company, these changes compare to placebo changes of about -0.25% at the same timepoints.

How was the safety and tolerability of ABBV-295 reported in the March 9, 2026 announcement?

The treatment was generally well tolerated with no serious adverse events reported during the MAD study. According to the company, most adverse events were mild gastrointestinal disorders occurring mainly in the first six weeks.

What dosing schedules and dose range were tested for ABBV-295 in the Phase 1 MAD study?

The study tested doses from 2 mg to 14 mg with weekly, every‑other‑week, and monthly (after week 5) schedules. According to the company, different titrations and frequencies were evaluated across cohorts.

How much weight did ABBV-295-treated participants lose compared to placebo in the Phase 1 study?

ABBV-295 groups showed mean weight reductions between -6.74% and -9.79% at weeks 12–13, versus about -0.25% in placebo. According to the company, results were dose-dependent and derived from MMRM LS mean estimates.

Who was enrolled in the ABBV-295 Phase 1 MAD study reported March 9, 2026?

The study enrolled adults with a mean BMI of 30 kg/m2, and participants were predominantly male (88.3%). According to the company, the cohort composition reflects the MAD study population reported in the topline release.