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NCT Number: NCT07654361

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

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.

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Key information

Conditions

Obesity Body Weight Chronic Weight Management Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ACCOMPLISH-1 Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aleniglipron

Drug

Drug: aleniglipron administered orally Drug

Placebo

Drug

Drug: placebo administered orally

Primary outcomes

  1. Percent change in body weight from Baseline

    Time frame: Baseline and Week 76

Secondary outcomes

  1. Change in body weight (absolute) from Baseline

    Time frame: Baseline and week 76

  2. Percentage of participants who achieve ≥5% reduction in body weight

    Time frame: Baseline and week 76

  3. Percentage of participants who achieve ≥10% reduction in body weight

    Time frame: Baseline and week 76

  4. Percentage of participants who achieve ≥15% reduction in body weight

    Time frame: Baseline and week 76

  5. Percentage of participants who achieve ≥20% reduction in body weight

    Time frame: Baseline and week 76

  6. Change in waist circumference from Baseline

    Time frame: Baseline and week 76

  7. Change in resting systolic blood pressure from Baseline

    Time frame: Baseline and week 76

  8. Percent change in fasting triglycerides and non-HDL cholesterol from Baseline

    Time frame: Baseline and week 76

  9. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline

    Time frame: Baseline and week 76

  10. Change in HbA1c from Baseline

    Time frame: Baseline and week 76

  11. Change in body mass index from Baseline

    Time frame: Baseline and week 76

  12. Percent change in fasting total cholesterol from Baseline

    Time frame: Baseline and week 76

  13. Change in fasting glucose from Baseline

    Time frame: Baseline and week 76

  14. Change in resting diastolic blood pressure from Baseline

    Time frame: Baseline and week 76

Other outcomes

  1. Percentage of participants who achieve ≥25% reduction in body weight

    Time frame: Baseline and week 76

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

1-650-457-1959

Sponsors and collaborators

Lead sponsor

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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