aleniglipron (GSBR-1290) / Structure Therap - LARVOL DELTA

Aleniglipron is currently being evaluated in the ongoing Phase 3 ACCOMPLISH program, comprising two randomized, double-blind, placebo-controlled clinical trials. (GlobeNewswire) - "ACCOMPLISH-1 (NCT07654361) is enrolling up to 3,600 adults living with obesity or overweight with at least one weight-related comorbidity, while ACCOMPLISH-2 (NCT07654374) is enrolling up to 1,100 adults living with obesity or overweight and type 2 diabetes mellitus (T2DM). In both trials, participants will receive placebo or one of three aleniglipron maintenance doses, 45 mg, 90 mg or 180 mg, following a 2.5 mg starting dose and dose escalation at four-week intervals. The program is designed to evaluate the long-term efficacy and safety of aleniglipron and support global regulatory marketing applications for chronic weight management. We expect topline data in the second half of 2028."

P3 data: top line • Trial status • Obesity • Type 2 Diabetes Mellitus

Aleniglipron (Oral Small Molecule Selective GLP-1 Receptor Agonist): ACCESS OLE Results (GlobeNewswire) - "Participants continued once-daily treatment in the OLE trial, with doses titrated every four weeks, while participants originally assigned to placebo crossed over to aleniglipron at Week 36 starting with a lower 2.5 mg dose...Participants originally randomized to the 45 mg, 90 mg and 120 mg arms in the ACCESS trial who continued into the OLE and dosed up to 180 mg, achieved weight loss of 11.6%, 14.4% and 16.2%, respectively, with no evidence of weight loss plateau in the two top doses. More than one-third of participants in the highest dose cohorts, 90 mg and 120 mg, achieved more than 20% body weight reduction, with mean absolute body weight loss of 35.9 and 40.5 pounds, respectively."

P2b data • Obesity

Upcoming Milestones in Q4 2026 (GlobeNewswire) - "Phase 2 Body Composition clinical trial (NCT07169942): Results from a 44-week study evaluating aleniglipron’s effects on body fat and overall body composition; Phase 2 T2DM clinical trial (NCT07400588): Results in adults living with T2DM and obesity or overweight; Phase 1 SWITCH clinical trial: Results evaluating the transition from approved injectable GLP-1 medicine to once-daily oral aleniglipron."

P1 data • P2 data • Obesity • Type 2 Diabetes Mellitus

Weight-lowering effects of aleniglipron, an oral small molecule GLP-1RA in the ACCESS study: continued weight loss and improved tolerability in open label extension study (EASD 2026) - P2 | "Data from the ACCESS Phase 2b trial and ongoing OLE support further development of aleniglipron for chronic weight management in Phase 3 registrational studies for people living with obesity and overweight."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2) (clinicaltrials.gov) - P3 | N=1100 | Recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) (clinicaltrials.gov) - P3 | N=3600 | Recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

ACCESS: A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=230 | Completed | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

The Company announced that the first patients have been dosed in the Phase 3 ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron, a once-daily oral small molecule GLP-1 receptor agonist (GlobeNewswire) - "ACCOMPLISH-1 and ACCOMPLISH-2 are randomized, double-blind, placebo-controlled clinical trials designed to evaluate the long-term efficacy and safety of three maintenance doses of aleniglipron."

Trial status • Obesity

Structure plans to report new data from the following aleniglipron clinical trials in the second half of 2026 (GlobeNewswire) - "(i) The ACCESS Open Label Extension (OLE) clinical trial is evaluating the tolerability of the dose titration regimen that includes a starting dose of 2.5 mg in placebo crossover patients....Data are expected in Q3 2026; (ii) The Body Composition clinical trial is assessing the effect of aleniglipron on body fat loss over a 44-week evaluation period. Data are expected in Q4 2026; (iii) The clinical trial in patients with T2DM with obesity/overweight is evaluating the potential for including participants with T2DM in the Phase 3 program. Data are expected in Q4 2026; (iv) The SWITCH clinical trial is assessing the transition from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for long-term weight loss maintenance. Data are expected in Q4 2026."

Clinical data • Trial status • Obesity • Type 2 Diabetes Mellitus

Combination of Oral Small Molecule GLP-1 and Amylin Receptor Agonists (GlobeNewswire) - "Preclinical combination data of aleniglipron and ACCG-2671 were presented at the ADA Scientific Sessions in June 2026 demonstrating additional weight loss compared to each monotherapy in non-human primates. A combination clinical trial is expected to be initiated in Q4 2026."

New trial • Preclinical • Obesity

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) (clinicaltrials.gov) - P3 | N=3600 | Not yet recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Trial completion date: Apr 2029 ➔ Nov 2028 | Trial primary completion date: Mar 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

New Trial Shows Oral GLP-1 Aleniglipron May Be the Future (Yahoo News) - "230 adults who are obese or overweight (average BMI ~39.5) were randomly assigned to take a placebo, or aleniglipron at one of three doses (45mg, 90mg, or 120mg) for 36 weeks, with the dose gradually increasing over time...On the highest dose, 86% of people lost at least 5% of their body weight, 70% lost at least 10%, and 38% lost at least 15%. Weight loss continued at the 36-week mark and never plateaued, which indicates that a longer trial would still see results...Bonus effects include improvements in blood pressure, blood sugar (HbA1c), and a marker of inflammation (CRP). These are most likely due to the weight loss itself rather than some other independent factor."

P2b data • Obesity

A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2) (clinicaltrials.gov) - P3 | N=1100 | Not yet recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

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 (ADA 2026) - "Combination therapy of long-acting peptides semaglutide and cagrilintide have demonstrated enhanced efficacy over single agents for obesity treatment in clinical trials. Combination treatment with the small molecule GLP-1R agonist aleniglipron and amylin receptor agonist ACCG-2671 demonstrated further weight loss than monotreatment in obese NHPs. These findings support further development of aleniglipron and ACCG-2671 as a potential oral fixed-dose combination therapy for obesity."

Late-breaking abstract • Metabolic Disorders • Obesity

Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial (ADA 2026) - "The ACCESS II Phase 2 trial results support the safety, tolerability, and efficacy of higher doses of the novel oral small molecule aleniglipron, and continued evaluation in phase 3 registrational trials for people living with obesity."

Clinical • P2 data • Metabolic Disorders • Obesity

ACCESS Trial: Dose-Ranging Evaluation of Aleniglipron, an Oral Small Molecule Nonpeptide GLP-1RA, Demonstrates Meaningful Weight Reductions in People Living with Obesity and Overweight (*This presentation will not be available on-demand.) (ADA 2026) - "ACCESS Phase 2b trial data support further development of aleniglipron, a novel, highly scalable, small-molecule GLP-1 RA and evaluation in Phase 3 registrational studies for people living with obesity."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) (clinicaltrials.gov) - P3 | N=3600 | Not yet recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

New P3 trial • Genetic Disorders • Obesity

Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials (ADA 2026) - "Starting aleniglipron at a lower dose (2.5 mg vs. 5 mg daily) is associated with a lower frequency of nausea and vomiting, suggesting better GI tolerability."

Late-breaking abstract • Metabolic Disorders • Obesity

ACCESS: Aleniglipron Achieves Up To 11.3% Weight Loss in Phase 2b Obesity Trial (HCPLive) - "The trial results were simultaneously published in Nature Medicine and presented at the 2026 American Diabetes Association (ADA) Scientific Sessions...The primary endpoint was met at all 3 dose levels (P <.0001 for each versus placebo). Placebo-adjusted LS mean body weight reductions were −8.2% (95% CI, −11.1 to −5.3%) in the 45-mg arm, −9.8% (95% CI, −12.5 to −7.2%) in the 90-mg arm, and −11.3% (95% CI, −13.9 to −8.6%) in the 120-mg arm. No weight loss plateau was apparent at the close of the double-blind period...An interim analysis of the ongoing open-label extension (OLE), after a median follow-up of 20 additional weeks, showed continued weight reduction, reaching mean total losses from randomization of 13.3%, 16.2%, and 15.3% in the 45-, 90-, and 120-mg arms, respectively, at week 56....No clinically meaningful changes in lipid profiles were observed."

P2b data • Obesity

Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. (PubMed, Nat Med) - P2 | "Clinically relevant weight reductions of up to 11.3% with a tolerability profile consistent with the GLP-1RA class support further development of aleniglipron for obesity treatment. ClinicalTrials.gov registration: NCT06693843 ."

Clinical • Journal • P2b data • Genetic Disorders • Hepatology • Liver Failure • Obesity

ACCESS II: A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=85 | Completed | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

ACCESS: A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=220 | Active, not recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Trial primary completion date: Jul 2026 ➔ Oct 2025

Trial primary completion date • Genetic Disorders • Obesity

GSBR-1290: Aleniglipron Phase 2 in Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Structure Therapeutics to Present Aleniglipron, Amylin and Combination Data at the American Diabetes Association 86th Scientific Sessions (GlobeNewswire) - "The presentations include an oral presentation on the ACCESS Phase 2b clinical trial of aleniglipron."

P2b data • Obesity

ACCESS II Study - Evaluating higher doses up to 240 mg (GlobeNewswire) - "In the Phase 2 ACCESS II study, aleniglipron achieved clinically meaningful and statistically significant placebo-adjusted mean weight loss of 16.3% (39 lbs; p<0.0001) at the 180 mg dose and 16.0% (37 lbs; p<0.0001) at the 240 mg dose at 44 weeks...Data from a pre-specified interim analysis after a median follow-up of 20 weeks demonstrated that starting at a lower dose of 2.5 mg for the first four weeks supported a manageable tolerability profile with meaningful improvements in AE-related discontinuations...Additionally, at a 2.5 mg start and after a median follow up of 20 weeks (~ 30 mg titration step) aleniglipron showed a 6.8% weight loss."

P2 data • Obesity