Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

NCT07654361
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
3,600
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Lead sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
clinicaltrials.gov
Start date
2026-07-13
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Number of sites
71
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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.
clinicaltrials.gov
Short title
Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-11-01
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First posted
2026-06-17
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Registry last updated
2026-08-10
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Primary completion date
2028-09-01
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Start date
2026-07-13
clinicaltrials.gov

Participants
3,600
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
3,600
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Protocol amendments
1
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Number of sites
71
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
clinicaltrials.gov
Source registry
ClinicalTrials.gov
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Registry ID
NCT07654361
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07654361
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent change in body weight from Baseline

    Timeframe: Baseline and Week 76

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
79 Years
Healthy volunteers
No

  • Signed informed consent
  • BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

  • 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
clinicaltrials.gov

  • 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
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)