Structure Therapeutics Announces Initiation of Phase 1 Clinical Study of Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity

Rhea-AI Summary

Structure Therapeutics (NASDAQ: GPCR) initiated a first-in-human Phase 1 study of ACCG-2671, an oral once-daily small molecule amylin receptor agonist for the treatment of obesity, on Dec. 17, 2025. ACCG-2671 was designed with the company’s structure-based GPCR drug discovery platform.

Preclinical data reported include potent target engagement, robust weight loss as monotherapy, additional weight loss in combination with a GLP-1 receptor agonist, favorable safety, and PK supporting once-daily dosing. The Phase 1 trial will assess safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and people with obesity using single-ascending and multiple-ascending dose cohorts.

Positive

• Phase 1 initiated for ACCG-2671 on Dec. 17, 2025
• Oral once-daily formulation with suitable PK reported in preclinical data
• Preclinical weight loss as monotherapy and added loss with GLP-1 RA
• First clinical amylin program entry from the company’s portfolio

Negative

• No human efficacy data yet — ACCG-2671 is at Phase 1 (first-in-human)
• Combination benefit shown only preclinically, not yet demonstrated in humans

Market Reality Check

$64.94 Last Close

Volume Volume 2,090,635 is below 20-day average of 2,608,592. normal

Technical Price 61.71 trades above 200-day MA of 25.04 after a strong prior uptrend.

Peers on Argus

GPCR was down 4.77% pre-news while peers in Biotechnology showed mixed moves (e.g., NUVB +2.49%, AMLX -2.84%), pointing to stock-specific dynamics rather than a broad sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 11	Equity offering close	Negative	-0.6%	Closing of upsized ADS and pre-funded warrant offering with $747.5M gross.
Dec 09	Equity offering pricing	Negative	-4.6%	Pricing of upsized $650M ADS and pre-funded warrant public offering.
Dec 08	Equity offering launch	Negative	+102.5%	Announcement of proposed $500M ADS and pre-funded warrant offering.
Dec 08	Phase 2b obesity data	Positive	+102.5%	Positive 36-week ACCESS topline results for oral GLP‑1 agonist aleniglipron.
Dec 07	Data release timing	Neutral	+102.5%	Announcement of upcoming ACCESS topline data release and investor webcast.

Pattern Detected

Clinical trial milestones have triggered very large positive moves, while equity offerings saw modest declines, indicating strong sensitivity to data readouts versus financing events.

Recent Company History

Over recent months, Structure Therapeutics combined major clinical and financing milestones. Positive Phase 2b ACCESS data for oral GLP‑1 agonist aleniglipron on Dec 8, 2025 drove a 102.49% move and set up Phase 3 planning. Around the same period, the company launched and closed upsized offerings totaling hundreds of millions of dollars, with mild negative reactions. Earlier in 2025, ACCESS data timing and ADA preclinical presentations for ACCG‑2671 built the obesity pipeline narrative that this new Phase 1 initiation advances.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-08-06

An effective automatic shelf registration on Form S-3ASR dated Aug 6, 2025 is in place and has not yet been used, giving the company flexibility to issue securities in the future without specifying any amount here.

Market Pulse Summary

This announcement adds a first-in-human Phase 1 trial for oral amylin receptor agonist ACCG-2671 to Structure’s obesity pipeline, complementing positive Phase 2b ACCESS data for aleniglipron. It follows substantial capital raises and an effective S-3ASR shelf, giving financial flexibility for development. Investors may track Phase 1 safety, pharmacokinetics and pharmacodynamics readouts, along with progress toward planned Phase 3 studies in obesity and related metabolic conditions.

Key Terms

amylin receptor agonist medical

"lead oral small molecule amylin receptor agonist for the treatment of obesity"

An amylin receptor agonist is a drug that activates the body’s amylin receptors to mimic the hormone amylin, which helps slow stomach emptying, reduce appetite, and regulate blood sugar. For investors, these medicines matter because clinical trial results, safety profiles, and regulatory approval determine their commercial potential in diabetes and obesity markets—similar to how a new feature can change a product’s appeal and sales prospects.

glucagon-like-peptide receptor agonist (GLP-1 RA) medical

"in combination with a glucagon-like-peptide receptor agonist (GLP-1 RA), a favorable"

A glucagon-like-peptide-1 receptor agonist (GLP-1 RA) is a type of medicine that copies a natural gut hormone to activate a specific receptor, helping the body release more insulin when needed, slow stomach emptying and reduce appetite. Think of it like a key that turns on signals controlling blood sugar and hunger. Investors care because these drugs address large markets (diabetes, obesity), can drive substantial sales, influence clinical and regulatory risk, and affect healthcare spending and company valuations.

pharmacokinetics medical

"a favorable safety profile, and pharmacokinetics profile suitable for once-daily dosing"

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.

pharmacodynamic medical

"evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of ACCG-2671"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

single-ascending dose medical

"The study will include single-ascending dose and multiple-ascending dose cohorts."

A single-ascending dose (SAD) study is an early-stage clinical test where small groups of volunteers each receive one single dose of a drug, with each subsequent group getting a higher dose if the previous dose is safe. Think of it like stepping up a staircase one step at a time to check stability; investors watch SAD results because they reveal initial safety, how the body handles the drug, and the safe dose range, all of which affect development risk and timelines.

multiple-ascending dose medical

"The study will include single-ascending dose and multiple-ascending dose cohorts."

A multiple-ascending dose study is an early-stage clinical trial where groups of volunteers receive a drug repeatedly at progressively higher dose levels to see how the body handles it and whether repeated dosing causes side effects. Think of it as gradually increasing the weight on a workout machine to find the safe, effective range; for investors, results reveal safety, how the drug behaves over time, and whether the program can move into larger, more costly trials.

monotherapy medical

"robust weight loss as a monotherapy and further weight loss when used"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

first-in-human Phase 1 clinical study medical

"announced that it has initiated a first-in-human Phase 1 clinical study of ACCG-2671"

A first-in-human phase 1 clinical study is the first time an experimental drug or therapy is given to a small group of people to check safety, how the body absorbs and clears it, and what dose levels are tolerated. For investors it is an early, high-risk milestone: positive findings reduce development risk and can increase a program's value, while safety problems or unclear signals can stop a program, like a prototype failing its initial flight test.

AI-generated analysis. Not financial advice.

SAN FRANCISCO, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced that it has initiated a first-in-human Phase 1 clinical study of ACCG-2671, the company’s lead oral small molecule amylin receptor agonist for the treatment of obesity. ACCG-2671 was designed via the company’s next generation structure-based drug discovery platform to harness the established metabolic benefits of amylin biology in an oral, once-daily small molecule, with the potential to improve scalability, combinability, and patient access.

“We believe amylin-based therapies are poised to become an important next-generation component of the treatment landscape for obesity and related conditions. Powered by our differentiated GPCR structure-based drug discovery platform, we have efficiently advanced ACCG-2671 into the clinic as the industry’s most advanced oral small molecule amylin therapy,” said Xichen Lin, Ph.D., Chief Scientific Officer of Structure Therapeutics. “Our platform enables the design of highly selective, orally available GPCR-targeted medicines. Preclinical data of ACCG-2671 show potent target engagement, robust weight loss as a monotherapy and further weight loss when used in combination with a glucagon-like-peptide receptor agonist (GLP-1 RA), a favorable safety profile, and pharmacokinetics profile suitable for once-daily dosing. ACCG-2671 has the potential to serve as a differentiated backbone therapy, both as a monotherapy and in combination with other weight loss medicines.”

The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of ACCG-2671 in both healthy volunteers and individuals with obesity. The study will include single-ascending dose and multiple-ascending dose cohorts.

“This has been a transformative year for Structure Therapeutics, marked by excellence in clinical execution and compelling validation of our oral small molecule approach to obesity and metabolic disease,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics. “Following the recent positive Phase 2 clinical data from our ACCESS program for aleniglipron, our once-daily oral small molecule GLP-1 receptor agonist, this initiation of our Phase 1 study of ACCG-2671 represents another major milestone and establishes the first clinical entry from our amylin portfolio. Together, these programs underscore the breadth and strength of our pipeline and our ability to translate proven metabolic biology into differentiated oral therapies that have the potential to broaden access and improve long-term treatment options for people living with obesity.”

About ACCG-2671 and Structure’s Amylin Portfolio
Amylin is co-secreted with insulin from pancreatic beta cells in response to nutrient ingestion. Amylin has important physiological effects including reducing appetite, increasing satiety, leptin sensitivity and energy expenditure. Preclinical data from current amylin-based treatments in development suggest a potential for amylin to reduce fat mass and preserve lean mass.

Two types of amylin-based treatments for the treatment of obesity are currently being developed: dual amylin and calcitonin receptor agonists (DACRAs) that target both the amylin and calcitonin receptors; and selective amylin receptor agonists (SARAs) that preferentially target the amylin receptor.

Structure Therapeutics is developing a series of both DACRAs and SARAs, as both approaches have demonstrated potential as obesity and chronic weight management treatment. Structure’s lead amylin-based molecule, ACCG-2671, is a DACRA that is being evaluated for use either alone or in combination with GLP-1R agonists to treat obesity and associated diseases. Structure is also advancing ACCG-3535, a second DACRA with a unique chemical structure from ACCG-2671. Structure is also developing SARA molecules, which are currently in preclinical development.

About Structure Therapeutics
Structure Therapeutics is a science-driven clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage oral small molecule compounds designed to surpass the scalability limitations of traditional biologic and peptide therapies and be accessible to more people living with obesity around the world. For additional information, please visit www.structuretx.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning: the Company’s future plans and prospects; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of ACCG-2671 and aleniglipron; the design of the Phase 1 study of ACCG-2671; the belief that amylin-based therapies are poised to become an important next-generation component of the treatment landscape for obesity and related conditions; the potential for ACCG-2671 to serve as a differentiated backbone therapy, both as a monotherapy and in combination with other weight loss medicines; the Company’s plans to develop a series of DACRAs and SARAs; the Company’s ability to translate proven metabolic biology into differentiated oral medicines that have the potential to broaden access and improve long-term treatment options for people living with obesity; the potential of DACRAs and SARAs as obesity and chronic weight management treatment; and any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials. In addition, when or if used in this press release, the words and phrases “anticipated,” “believe,” “expect,” “may,” “on track,” “plan,” “potential,” “suggests,” “to be,” “to begin,” “will,” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation: risks and uncertainties related to topline results that the Company reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the results due to the length of the study and sample size and the results from earlier clinical studies not necessarily being predictive of future results; potential delays in the commencement, enrollment and completion of the Company’s planned clinical studies; the Company’s ability to advance aleniglipron, ACCG-2671, ACCG-3535, ANPA-0073, LTSE-2578, and its other therapeutic candidates, obtain regulatory approval of, and ultimately commercialize the Company’s therapeutic candidates; competitive products or approaches limiting the commercial value of the Company’s product candidates; the timing and results of preclinical and clinical studies; the Company’s ability to fund development activities and achieve development goals; the Company's reliance on third parties, including clinical research organizations, manufacturers, suppliers and collaborators, over which it may not always have full control; general geopolitical and macroeconomic conditions, including as a result of tariffs and various global conflicts; the Company’s ability to protect its intellectual property; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Quarterly Report on Form 10-Q and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investors:
Danielle Keatley
Structure Therapeutics Inc.
ir@structuretx.com

Media:
Dan Budwick
1AB
Dan@1abmedia.com

FAQ

What did Structure Therapeutics announce about ACCG-2671 (GPCR) on December 17, 2025?

The company initiated a first-in-human Phase 1 study of ACCG-2671, an oral small molecule amylin receptor agonist for obesity.

What will the Phase 1 study of ACCG-2671 (GPCR) evaluate and who will be enrolled?

The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and individuals with obesity, using single- and multiple-ascending dose cohorts.

What preclinical results did Structure Therapeutics report for ACCG-2671 (GPCR)?

Preclinical data showed potent target engagement, robust weight loss as monotherapy, additional weight loss with a GLP-1 RA, favorable safety, and PK suitable for once-daily dosing.

How does ACCG-2671 (GPCR) differ from injectable amylin or GLP-1 therapies?

ACCG-2671 is described as an oral once-daily small molecule amylin receptor agonist designed for scalability, combinability, and improved patient access compared with injectable therapies.

Does ACCG-2671 (GPCR) have human efficacy or approval yet?

No; ACCG-2671 has entered Phase 1 and does not yet have human efficacy data or regulatory approval.