Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Study ID
- NCT07400588
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Obese
- Obesity
- Obesity Type 2 Diabetes Mellitus
- Weight Loss
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 79 Years
- Healthy Volunteers
- Not accepted
Interventions
- Aleniglipron — DRUGDrug aleniglipron administered orally
- Placebo — DRUGDrug placebo administered orally
Study Details
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).
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Apr 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 58 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1: Participants will receive aleniglipron administered orallyDrug aleniglipron administered orally
- Experimental: Arm 2: Participants will receive a placebo administered orallyDrug placebo administered orally
Primary Outcome Measure
Incidence, severity and relationship of AEs/SAEs [ Time Frame: Baseline to week 31 ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Anniston | Alabama | 36207 | - |
| Research Site | Lake Forest | California | 92630 | - |
| Research Site | Lomita | California | 90717 | - |
| Research Site | Hazelwood | Missouri | 63042 | - |
| Research Site | Columbus | Ohio | 43212 | - |
| Research Site | Moncks Corner | South Carolina | 29461 | - |
| Research Site | Chattanooga | Tennessee | 37421 | - |
| Research Site | Knoxville | Tennessee | 37909 | - |
| Research Site | Austin | Texas | 78704 | - |
| Research Site | DeSoto | Texas | 75115 | - |
| Research Site | Houston | Texas | 77079 | - |
| Research Site | Mesquite | Texas | 75149 | - |
| Research Site | San Antonio | Texas | 78215 | - |
| Research Site | San Antonio | Texas | 78229 | - |
| Research Site | San Antonio | Texas | 78240 | - |
| Research Site | Tomball | Texas | 77375 | - |
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