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

June 12, 2026 updated by: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Participants will receive aleniglipron administered orally.
Drug: aleniglipron
Drug: aleniglipron administered orally
Experimental: Cohort 2
Participants will receive aleniglipron administered orally.
Drug: aleniglipron
Drug: aleniglipron administered orally
Experimental: Cohort 3
Participants will receive aleniglipron administered orally.
Drug: aleniglipron
Drug: aleniglipron administered orally
Placebo Comparator: Cohort 4
Participants will receive placebo administered orally.
Drug: Placebo
Drug: placebo administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in body weight from Baseline
Time Frame: Baseline and week 76
Baseline and week 76

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body weight (absolute) from Baseline
Time Frame: Baseline and week 76
Baseline and week 76
Percentage of participants who achieve ≥5% reduction in body weight
Time Frame: Baseline and week 76
Baseline and week 76
Percentage of participants who achieve ≥10% reduction in body weight
Time Frame: Baseline and week 76
Baseline and week 76
Percentage of participants who achieve ≥15% reduction in body weight
Time Frame: Baseline and week 76
Baseline and week 76
Change in waist circumference from Baseline
Time Frame: Baseline and week 76
Baseline and week 76
Change in HbA1c from Baseline
Time Frame: Baseline and week 76
Baseline and week 76
Change in resting systolic blood pressure from Baseline
Time Frame: Baseline and week 76
Baseline and week 76
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
Time Frame: Baseline and week 76
Baseline and week 76
Percentage of participants achieving HbA1c target value of ≤6.5%
Time Frame: Baseline and week 76
Baseline and week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSBR-1290-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Gasherbrum Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes:

  • Re-evaluating safety and efficacy end points already addressed in the product labelling,
  • Assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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