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NCT Number: NCT07654374

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

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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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 Type2 Diabetes Mellitus

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ACCOMPLISH-2 Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Aleniglipron

Drug

Drug: aleniglipron administered orally

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. Change in waist circumference from Baseline

    Time frame: Baseline and week 76

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

    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 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)

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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