Aleniglipron Phase 2 in Type 2 Diabetes Mellitus (GSBR-1290)

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

Status and phase: Enrolling; Phase 2

Conditions: Weight Loss; Obese; Obesity; Obesity Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Aleniglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT07400588

GSBR-1290-17

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Arm 1: Participants will receive aleniglipron administered orally

Experimental group

Description:

Drug aleniglipron administered orally

Treatment:

Drug: Aleniglipron

Arm 2: Participants will receive a placebo administered orally

Experimental group

Description:

Drug placebo administered orally

Treatment:

Drug: Placebo