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Completed
NCT07400588
Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
Conditions: Obese, Obesity, Obesity Type 2 Diabetes Mellitus, Weight Loss
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 58
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Location: Research Site Anniston Alabama
Summary
The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 180 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 Criteria
Inclusion Criteria:
* Signed Informed Consent
* A diagnosis of T2DM of ≥6 months,
* On stable treatment for T2DM for at least 90 days prior to Screening
* 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
Source: ClinicalTrials.gov (NCT07400588). StuddyBuddy aggregates publicly available trial information.