Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06693843

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Obesity, Overweight, or Chronic Weight Management Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ACCESS Research Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

aleniglipron or placebo

Drug

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Aleniglipron

Drug

Drug: Aleniglipron Administered orally

Primary outcomes

  1. Percent change in body weight from Baseline to Week 36

    Time frame: Baseline and week 36

    Double Blind Period

  2. TEAEs and SAEs

    Time frame: Baseline and week 72

    Open -Label Extension

  3. AESI

    Time frame: Baseline and week 72

    Open -Label Extension

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

    Time frame: Baseline and week 72

    Open -Label Extension

  5. 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)

    Time frame: Baseline and week 72

    Open -Label Extension

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

    Time frame: Baseline and week 72

    Open -Label Extension

Secondary outcomes

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

    Time frame: Baseline and week 36

    Double Blind Period

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

    Time frame: Baseline and week 36

    Double Blind Period

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

    Time frame: Baseline and week 36

    Double Blind Period

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

    Time frame: Baseline and week 36

    Double Blind Period

  5. Change in waist circumference from Baseline to Week 36

    Time frame: Baseline and week 36

    Double Blind Period

  6. Change in body mass index from Baseline to Week 36

    Time frame: Baseline and week 36

    Double Blind Period

  7. Percent change in body weight

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

    Open -Label Extension

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

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

    Open -Label Extension

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

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

    Open -Label Extension

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

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

    Open -Label Extension

  11. Change in body weight

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

    Open -Label Extension

  12. Change in body mass

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

    Open -Label Extension

  13. Change in waist circumference

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

    Open -Label Extension

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity

Acronym: ACCESS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.