RecruitingPhase 2NCT07400588
Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
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
Sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Enrollment
50 participants
Start Date
Dec 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 79 Years
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
DRUGAleniglipron
Drug aleniglipron administered orally
DRUGPlacebo
Drug placebo administered orally
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT07400588
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