A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (ACCESS)

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; Drug: Aleniglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06693843

GSBR-1290-06

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

Exclusion criteria

• Previous documented diagnosis of diabetes mellitus.
• Self-reported change in body weight >5% within 3 months before Screening
• Body weight ≤80 kg at Screening
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 7 patient groups

Cohort 1

Experimental group

Description:

Participants will receive Aleniglipron or Placebo administered orally.

Treatment:

Drug: Aleniglipron or Placebo

Drug: Aleniglipron or Placebo

Drug: Aleniglipron or Placebo

Cohort 2

Experimental group

Description:

Participants will receive Aleniglipron or Placebo administered orally.

Treatment:

Drug: Aleniglipron or Placebo

Drug: Aleniglipron or Placebo

Drug: Aleniglipron or Placebo

Cohort 3

Experimental group

Description:

Participants will receive Aleniglipron or Placebo administered orally.

Treatment:

Drug: Aleniglipron or Placebo

Drug: Aleniglipron or Placebo

Drug: Aleniglipron or Placebo

Cohort 1 OLE

Active Comparator group

Description:

Participants will receive Aleniglipron administered orally

Treatment:

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Cohort 2 OLE

Active Comparator group

Description:

Participants will receive Aleniglipron administered orally

Treatment:

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Cohort 3 OLE

Active Comparator group

Description:

Participants will receive Aleniglipron administered orally

Treatment:

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Cohort 4 OLE

Active Comparator group

Description:

Participants will receive Aleniglipron administered orally

Treatment:

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron

Drug: Aleniglipron