Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Obese, Obesity, Obesity Type 2 Diabetes Mellitus, Weight Loss

In brief

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 facts

Study ID

NCT07400588

Run by

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

People needed

58

Starts

2025-12-01

Expected to finish

2026-09-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Research Site — Anniston, Alabama, United States
• Research Site — Lake Forest, California, United States
• Research Site — Lomita, California, United States
• Research Site — Hazelwood, Missouri, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Moncks Corner, South Carolina, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — DeSoto, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Mesquite, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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