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Completed

NCT Number: NCT06703021

A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.

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Key information

Conditions

Obesity Body Weight Chronic Weight Management Nutrition Disorders Nutritional and Metabolic Diseases 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 II Research Site, Glendale, California, 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
  • Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
  • Use of medications intended to promote weight loss, within 6 months prior to Screening

Treatment and study plan

aleniglipron or placebo

Drug

Drug: aleniglipron administered orally; Drug: placebo administered orally

Primary outcomes

  1. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Baseline and week 44

  2. Adverse events of special interest

    Time frame: Baseline and week 44

  3. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis

    Time frame: Baseline and week 44

  4. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration

    Time frame: Baseline and week 44

  5. Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature

    Time frame: Baseline and week 44

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)

    Time frame: Baseline and week 44

  2. Maximum Observed Plasma Concentration (Cmax) of aleniglipron

    Time frame: Baseline and week 44

  3. Trough Concentrations (Ctrough) of aleniglipron

    Time frame: Baseline and week 44

  4. Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron

    Time frame: Baseline and week 44

  5. Terminal Elimination Half-life (t1/2) for aleniglipron

    Time frame: Baseline and week 44

Other outcomes

  1. Percent change in body weight

    Time frame: Baseline and week 44

  2. Change in body weight (absolute)

    Time frame: Baseline and week 44

  3. Percentage of participants who achieve ≥5% reduction in body weight at Week 44

    Time frame: Baseline and week 44

  4. Percentage of participants who achieve ≥10% reduction in body weight at Week 44

    Time frame: Baseline and week 44

  5. Percentage of participants who achieve ≥15% reduction in body weight at Week 44

    Time frame: Baseline and week 44

  6. Change in waist circumference

    Time frame: Baseline and week 44

  7. Change in body mass index

    Time frame: Baseline and week 44

  8. Change in patient-reported outcomes (hunger and satiety questionnaire)

    Time frame: Baseline and week 44

  9. Change in HDL and LDL cholesterol

    Time frame: Baseline and week 44

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal 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 (ACCESS II)

Acronym: ACCESS II

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 25, 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.

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