Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

NCT07400588 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GSBR-1290-17
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).

Conditions

Obese; Obesity; Obesity Type 2 Diabetes Mellitus; Weight Loss

Keywords

Obese; obesity; Obesity Type 2 Diabetes; Weight Loss

Outcome Measures

Primary Outcomes (4)

• Incidence, severity and relationship of AEs/SAEs

  Baseline to week 31

• Assessment of vital signs

  Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.

  Baseline to week 31

• Assessment of laboratory measures

  Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation

  Baseline to week 31

• Assessment of Electrocardiograms (ECG)

  Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF

  Baseline to week 31

Secondary Outcomes (8)

• Absolute change in body weight from Baseline

  Baseline to week 31

• Percent change in body weight from Baseline

  Baseline to week 31

• Change in HbA1c from Baseline

  Baseline to week 30

• Change in fasting plasma glucose from Baseline

  Baseline to week 31

• PK parameters including but not limited to AUC

  Baseline to week 30

Study Arms (2)

Arm 1: Participants will receive aleniglipron administered orally

EXPERIMENTAL

Drug aleniglipron administered orally

Drug: Aleniglipron

Arm 2: Participants will receive a placebo administered orally

EXPERIMENTAL

Drug placebo administered orally

Drug: Placebo

Interventions

Aleniglipron DRUG

Drug aleniglipron administered orally

Arm 1: Participants will receive aleniglipron administered orally

Placebo DRUG

Drug placebo administered orally

Arm 2: Participants will receive a placebo administered orally

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• A diagnosis of T2DM of ≥6 months,
• Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening
• Have a BMI ≥27.0 kg/m2

You may not qualify if:

• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema.
• Present or planned use of any drug that could interfere with glucose levels
• Self-reported change in body weight \>5 kg (11 pounds) within 3 months before screening
• Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to Screening)
• Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner

Sponsors & Collaborators

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

Study Sites (16)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Lake Forest, California, 92630, United States

Location

Research Site

Lomita, California, 90717, United States

Location

Research Site

Hazelwood, Missouri, 63042, United States

Location

Research Site

Columbus, Ohio, 43212, United States

Location

Research Site

Moncks Corner, South Carolina, 29461, United States

Location

Research Site

Chattanooga, Tennessee, 37421, United States

Location

Research Site

Knoxville, Tennessee, 37909, United States

Location

Research Site

Austin, Texas, 78704, United States

Location

Research Site

DeSoto, Texas, 75115, United States

Location

Research Site

Houston, Texas, 77079, United States

Location

Research Site

Mesquite, Texas, 75149, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

San Antonio, Texas, 78240, United States

Location

Research Site

Tomball, Texas, 77375, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: February 10, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (16)