A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

NCT07654374
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,100
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Lead sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
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Start date
2026-07-17
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Number of sites
74
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Summary
This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.
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Short title
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
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Official title
A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
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Control arm
Placebo
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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
2026-07-17
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Participants
1,100
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Participant count basis
Estimated
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Planned participants
1,100
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Protocol amendments
1
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Number of sites
74
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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
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07654374
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07654374
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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. Change in waist circumference from Baseline

    Timeframe: Baseline and week 76

  6. Change in HbA1c 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. Percentage of participants achieving HbA1c target value of ≤6.5%

    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
Yes

  • Signed Informed Consent
  • Have a BMI ≥27.0 kg/m2 at Screening
  • Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening

  • Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Self-reported change in body weight >5 kg (11 pounds) within 3 months before Screening.
  • Have prior or planned surgical or non-surgical treatment for obesity.
Sources for eligibility
clinicaltrials.gov

  • ACCOMPLISH-2 Research SiteBirmingham, United StatesRecruiting
  • ACCOMPLISH-2 Research SiteChandler, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SitePhoenix, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteSun City West, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteTucson, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteLittle Rock, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteEscondido, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteFountain Valley, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteLake Forest, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteRolling Hills Estates, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteSan Diego, United StatesRecruiting
  • ACCOMPLISH-2 Research SiteSan Diego, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteTustin, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteWaterbury, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteClearwater, United StatesRecruiting
  • ACCOMPLISH-2 Research SiteFort Myers, United StatesRecruiting
  • ACCOMPLISH-2 Research SiteJacksonville, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteLeesburg, United StatesRecruiting
  • ACCOMPLISH-2 Research SiteMiami, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteOcala, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteOcoee, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SitePembroke Pines, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteAtlanta, United StatesRecruiting
  • ACCOMPLISH-2 Research SiteColumbus, United StatesNot yet recruiting
  • ACCOMPLISH-2 Research SiteLawrenceville, United StatesNot yet recruiting

And 49 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)