Aleniglipron Phase 2 Body Composition Study

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

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity, Overweight, or Chronic Weight Management

Treatments: Drug: aleniglipron or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07169942

GSBR-1290-16

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.

Enrollment: 71 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2
• Screening HbA1c <6.5 %

Exclusion criteria

• Previous documented diagnosis of diabetes mellitus
• Self-reported change in body weight >5% within 3 months before Screening
• Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
• Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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71 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Participants will receive aleniglipron or placebo administered orally.

Treatment:

Drug: aleniglipron or placebo

Cohort 2

Experimental group

Description:

Participants will receive aleniglipron or placebo administered orally.

Treatment:

Drug: aleniglipron or placebo