> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-aleniglipron-in-participants-with-d91c444e-76ab-4255-8e93-1c86f7a8e44d > Record changed: 2026-10-13 # Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) NCT07654361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) Participants 3,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) Lead sponsor Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) Start date 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) Number of sites 71 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Title and summary **Summary** Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Short title** Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Official title** A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Dates **Completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **First posted** 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Primary completion date** 2028-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Start date** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Size and sites **Participants** 3,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Planned participants** 3,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Number of sites** 71 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Lead sponsor** Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Identifiers **Registry ID** NCT07654361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **ClinicalTrials.gov ID** NCT07654361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Outcomes ### Primary outcomes 1. Percent change in body weight from Baseline Timeframe: Baseline and Week 76 ### Secondary outcomes 1. Change in body weight (absolute) from Baseline Timeframe: Baseline and week 76 2. Percentage of participants who achieve ≥5% reduction in body weight Timeframe: Baseline and week 76 3. Percentage of participants who achieve ≥10% reduction in body weight Timeframe: Baseline and week 76 4. Percentage of participants who achieve ≥15% reduction in body weight Timeframe: Baseline and week 76 5. Percentage of participants who achieve ≥20% reduction in body weight Timeframe: Baseline and week 76 6. Change in waist circumference from Baseline Timeframe: Baseline and week 76 7. Change in resting systolic blood pressure from Baseline Timeframe: Baseline and week 76 8. Percent change in fasting triglycerides and non-HDL cholesterol from Baseline Timeframe: Baseline and week 76 9. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline Timeframe: Baseline and week 76 10. Change in HbA1c from Baseline Timeframe: Baseline and week 76 11. Change in body mass index from Baseline Timeframe: Baseline and week 76 12. Percent change in fasting total cholesterol from Baseline Timeframe: Baseline and week 76 13. Change in fasting glucose from Baseline Timeframe: Baseline and week 76 14. Change in resting diastolic blood pressure from Baseline Timeframe: Baseline and week 76 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 79 Years **Healthy volunteers** No ### Inclusion criteria - Signed informed consent - BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. ### Exclusion criteria - Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes. - Self-reported change in body weight >5 kg within 3 months before Screening. - Have prior or planned surgical or non-surgical treatment for obesity. - Have or plan to have endoscopic and/or device-based therapy for obesity. - Have obesity induced by other endocrine disorders. - Impaired renal function at Screening - Chronic malabsorption Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Sites - ACCOMPLISH-1 Research SiteBirmingham, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteBirmingham, United StatesNot yet recruiting - ACCOMPLISH-1 Research SitePhoenix, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteSun City West, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteTucson, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteEscondido, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteGardena, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteLa Jolla, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteModesto, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteRolling Hills Estates, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteSan Diego, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteClearwater, United StatesRecruiting - ACCOMPLISH-1 Research SiteLeesburg, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteMiami, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteOcala, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteOcoee, United StatesNot yet recruiting - ACCOMPLISH-1 Research SitePembroke, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteTampa, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteBuford, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteColumbus, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteLawrenceville, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteUnion City, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteWoodstock, United StatesNot yet recruiting - ACCOMPLISH-1 Research SiteHonolulu, United StatesRecruiting - ACCOMPLISH-1 Research SiteMeridian, United StatesNot yet recruiting And 46 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07654361) ## Related records ### Drugs (1) - [Aleniglipron](https://trialight.com/data/asset/aleniglipron-de94eeab-2748-4d16-98b0-aef79b483e8c.md) ### Lead sponsors (1) - [Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics](https://trialight.com/data/company/gasherbrum-bio-inc-a-wholly-owned-subsidiary-of-structure-27ed27ee-e715-4760-98f8-c7c39c7874ee.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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