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
Status: Active_not_recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Research Site
Anniston
California
Research Site
Lake Forest
Research Site
Lomita
Missouri
Research Site
Hazelwood
Ohio
Research Site
Columbus
South Carolina
Research Site
Moncks Corner
Tennessee
Research Site
Chattanooga
Research Site
Knoxville
Texas
Research Site
Austin
Research Site
Desoto
Research Site
Houston
Research Site
Mesquite
Research Site
San Antonio
Research Site
San Antonio
Research Site
San Antonio
Research Site
Tomball
Time Frame
Start Date: 2025-12-01
Completion Date: 2026-09
Participants
Target number of participants: 58
Treatments
Experimental: Arm 1: Participants will receive aleniglipron administered orally
Drug aleniglipron administered orally
Experimental: Arm 2: Participants will receive a placebo administered orally
Drug placebo administered orally
Related Therapeutic Areas
Sponsors
Leads: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics