Aleniglipron Phase 2 in Type 2 Diabetes Mellitus (GSBR-1290)

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety and Tolerability of Aleniglipron in Adult Participants With Type 2 Diabetes Mellitus Living With Obesity or Overweight

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Weight Loss; Obese; Obesity Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Aleniglipron; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Research Site
  • California
    • Lake Forest, California, United States, 92630
      • Research Site
    • Lomita, California, United States, 90717
      • Research Site
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Research Site
  • South Carolina
    • Moncks Corner, South Carolina, United States, 29461
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Research Site
    • Knoxville, Tennessee, United States, 37909
      • Research Site
  • Texas
    • Austin, Texas, United States, 78704
      • Research Site
    • DeSoto, Texas, United States, 75115
      • Research Site
    • Houston, Texas, United States, 77079
      • Research Site
    • Mesquite, Texas, United States, 75149
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78215
      • Research Site
    • San Antonio, Texas, United States, 78240
      • Research Site
    • Tomball, Texas, United States, 77375
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Participants will receive aleniglipron administered orally; Drug aleniglipron administered orally	Drug: Aleniglipron; Drug aleniglipron administered orally
Experimental: Arm 2: Participants will receive a placebo administered orally; Drug placebo administered orally	Drug: Placebo; Drug placebo administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
PK parameters including but not limited to Cmax	Baseline to week 30
PK parameters including but not limited to Tmax	Baseline to week 30
PK parameters including but not limited to Ctrough	Baseline to week 30

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; Obese; Weight Loss; Obesity Type 2 Diabetes
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss
• Other Study ID Numbers: GSBR-1290-17

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