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

Phase 2Active Not RecruitingNCT06693843

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

220

Conditions

Obesity, Overweight, or Chronic Weight Management

Interventions

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Aleniglipron or PlaceboDRUG

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Aleniglipron or PlaceboDRUG

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

AleniglipronDRUG

Drug: Aleniglipron Administered orally

AleniglipronDRUG

Drug: Aleniglipron Administered orally

AleniglipronDRUG

Drug: Aleniglipron Administered orally

AleniglipronDRUG

Drug: Aleniglipron Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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)

Locations (39)

ACCESS Research Site

Phoenix, Arizona, United States

ACCESS Research Site

Anaheim, California, United States

ACCESS Research Site

Los Angeles, California, United States

ACCESS Research Site

Montclair, California, United States

ACCESS Research Site

Rancho Cucamonga, California, United States

Outcomes

Primary Outcomes

Percent change in body weight from Baseline to Week 36

Double Blind Period

Time frame: Baseline and week 36

TEAEs and SAEs

Open -Label Extension

Time frame: Baseline and week 72

AESI

Open -Label Extension

Time frame: Baseline and week 72

Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation

Open -Label Extension

Time frame: Baseline and week 72

Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)

Open -Label Extension

Time frame: Baseline and week 72

Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature

Open -Label Extension

Time frame: Baseline and week 72

Secondary Outcomes

Percentage of participants who achieve ≥5% reduction in body weight at Week 36

Double Blind Period

Time frame: Baseline and week 36

Percentage of participants who achieve ≥10% reduction in body weight at Week 36

Double Blind Period

Time frame: Baseline and week 36

Percentage of participants who achieve ≥15% reduction in body weight at Week 36

Double Blind Period

Time frame: Baseline and week 36

Change in body weight (absolute) from Baseline to Week 36

Double Blind Period

Time frame: Baseline and week 36

Change in waist circumference from Baseline to Week 36

Double Blind Period

Time frame: Baseline and week 36

Change in body mass index from Baseline to Week 36

Double Blind Period

Time frame: Baseline and week 36

Percent change in body weight

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Percentage of participants who achieve ≥5% reduction in body weight

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Percentage of participants who achieve ≥10% reduction in body weight

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Percentage of participants who achieve ≥15% reduction in body weight

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Change in body weight

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Change in body mass

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Change in waist circumference

Open -Label Extension

Time frame: Baseline to week 72 & Week 36-72

Data from ClinicalTrials.gov

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ACCESS Research Site

Sacramento, California, United States

ACCESS Research Site

Spring Valley, California, United States

ACCESS Research Site

Honolulu, Hawaii, United States

ACCESS Research Site

Chicago, Illinois, United States

ACCESS Research Site

Chicago, Illinois, United States

...and 29 more locations