Publication presented concurrently with oral presentation at
American Diabetes Association’s 86th Scientific Sessions from ACCESS development program with aleniglipron, a once-daily oral small molecule GLP-1 receptor agonist
Publication and presentation detail dose-dependent, clinically meaningful and
statistically significant reductions in body weight with continued weight loss beyond 36 weeks,
up to 16.2% during the open-label extension
Aleniglipron safety profile reflects well-known GI-related GLP-1 class adverse events,
with favorable tolerability profile demonstrated by an overall low (10.4%) discontinuation rate
Phase 3 program remains on track to initiate in Q3 2026
Additional presentations related to Structure’s obesity pipeline, including amylin and combination data, expected at the American Diabetes Association’s 86th Scientific Sessions
SAN FRANCISCO, June 05, 2026 (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 a publication in Nature Medicine detailing results from the Phase 2b ACCESS clinical trial of aleniglipron for the treatment of people living with obesity and/or overweight with at least one weight related co-morbidity.
The Nature Medicine publication, titled, “Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial,” can be accessed online at: https://www.nature.com/articles/s41591-026-04476-6. The publication was released concurrent with an oral presentation during the American Diabetes Association’s 86th Scientific Sessions by lead author, Julio Rosenstock, MD, Chair of the aleniglipron program Steering Committee and Clinical Professor of Medicine, University of Texas, Southwestern Medical Center.
The data highlights the efficacy from three maintenance dose levels in the core Phase 2b ACCESS study, as well as a predefined interim analysis of the open-label extension (OLE) safety study that demonstrated the durability of weight loss beyond 36 weeks, and improved tolerability from a lower 2.5 mg starting dose. The data from these studies provide support for the study design of the upcoming Phase 3 program which is expected to initiate in the third quarter of 2026.
“The data published today provide important new details around the previously reported reductions in body weight in patients dosed with aleniglipron. Interestingly, participants continued to lose weight after a median follow up of 20 weeks in the open label extension phase of the study after finalizing the 36 weeks in the double-blind treatment period, with no apparent weight loss plateau. This is an important distinction for a once-daily oral, non-peptide GLP-1 receptor agonist to potentially become an additional treatment option for patients,” stated Dr. Rosenstock, MD, Chair of the Steering Committee. “The study closely monitored the participant experience and additional impacts across key measures of tolerability, including the ability to restart or increase dosing titration after interruption without substantial increase in emesis events, which may be helpful for clinicians to gain a clinical perspective of treatment tolerance.”
Aleniglipron is an oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) in development for the treatment of obesity. As previously reported, at Week 36, each of the three doses in the ACCESS study achieved statistical significance on the primary endpoint and all key secondary endpoints. Other cardiovascular risk factors showed improvement with aleniglipron, such as systolic and diastolic blood pressure, hsCRP, waist circumference and HbA1c, which could positively contribute to the known cardiovascular benefits of approved GLP-1s. The interim analysis from the OLE study showed that patients continued to lose weight after a median follow up of 20 weeks, with weight loss of 13.3%, 16.2%, and 15.3% in the participants coming from 45 mg, 90 mg, and 120 mg aleniglipron arms from the double-blind treatment period, respectively.
As seen in prior studies, adverse events (AEs) in the patients treated with aleniglipron are similar to those seen in the GLP-1 class of medicines. Gastrointestinal (GI) events were generally mild to moderate and decreased in frequency over time and most patient discontinuations occurred during the initial titrations in dose.
There was no apparent dose-response relationship for the most common GI AEs across all aleniglipron treatment arms, and treatment discontinuations due to any treatment related adverse event (TEAE) were limited. The heat maps of dose levels overlaid with vomiting events add clarity to interpretation of the AE profile and add valuable insights into the participant experience on aleniglipron. Upon examination of each participant’s dosing across the study, it becomes clear that although some participants required dose interruptions or reductions, when the dose was re-initiated or up-titrated again, vomiting rarely recurred. This suggests that participants on aleniglipron may successfully restart treatment or continue to increase dosing after an interruption. This could potentially increase the likelihood to remain on treatment for extended periods of time, which is essential for a clinically meaningful treatment of obesity.
“We are pleased to have the ACCESS study data published in Nature Medicine to provide additional details about the important outcomes from this trial. We are on track to initiate our Phase 3 program of aleniglipron in the third quarter of 2026 with a starting dose of 2.5 mg and the intent to evaluate multiple doses based on this data and our End of Phase 2 meeting with the FDA,” said Blai Coll, M.D., Ph.D., Chief Medical Officer of Structure Therapeutics. “We are confident in the potential for once-daily oral aleniglipron to transform the treatment of obesity for patients around the world.”
In addition, Structure Therapeutics will have multiple other presentations related to its obesity pipeline, including amylin and combination data, at the ADA 86th Scientific Sessions. Details of the additional presentations are as follows:
Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials
Session: Late Breaking Poster Session (3101-LB)
Date: Sunday, June 7
Time: 12:30 p.m. – 1:30 p.m. CT
Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs
Session: Late Breaking Poster Session (3061-LB)
Date: Sunday, June 7
Time: 12:30 p.m. – 1:30 p.m. CT
Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists
Session: Late Breaking Poster Session (3062-LB)
Date: Sunday, June 7
Time: 12:30 p.m. – 1:30 p.m. CT
Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial
Session: General Poster Session (2637-P)
Date: Monday, June 8
Time: 12:30 p.m. – 1:30 p.m. CT
Copies of these presentations will be made available on the Structure Therapeutics website at https://structuretx.com/publications/.
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; the planned initiation of the aleniglipron Phase 3 study and the timing thereof; any expectations regarding the potential benefits, tolerability and safety profile, accessibility, scalability, combinability, capability, efficacy, convenience, expected effects and future application of aleniglipron and any other of the Company’s investigational compounds; 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 Phase 3 clinical program and other clinical studies; the Company’s ability to advance aleniglipron, ACCG-2671, LTSE-2578, ACCG-3535, 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 Company’s ability to fund development activities and achieve development goals; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s latest Annual Report on Form 10-K 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:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
212-915-2577
[email protected]
Jun Yoon
Structure Therapeutics Inc.
[email protected]
Media:
Dan Budwick
1AB
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