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Recruiting NCT07654361

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

Phase III Interventional Obesity Overweight Chronic Weight Management

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aleniglipron, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight, Chronic Weight Management. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

Overview

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Interventions

  • Drug Aleniglipron
    Drug: aleniglipron administered orally Drug
  • Drug Placebo
    Drug: placebo administered orally

Primary outcome measures

  • Percent change in body weight from Baseline [Time frame: Baseline and Week 76]
Secondary outcome measures (12)
  • Change in body weight (absolute) from Baseline [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥5% reduction in body weight [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥10% reduction in body weight [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥15% reduction in body weight [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥20% reduction in body weight [Time frame: Baseline and week 76]
  • Change in waist circumference from Baseline [Time frame: Baseline and week 76]
  • Change in resting systolic blood pressure from Baseline [Time frame: Baseline and week 76]
  • Percent change in fasting triglycerides and non-HDL cholesterol from Baseline [Time frame: Baseline and week 76]
  • Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline [Time frame: Baseline and week 76]
  • Change in HbA1c from Baseline [Time frame: Baseline and week 76]
  • Change in body mass index from Baseline [Time frame: Baseline and week 76]
  • Percent change in fasting total cholesterol from Baseline [Time frame: Baseline and week 76]

Eligibility criteria

Inclusion criteria

  • Signed informed consent
  • BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

Exclusion criteria

  • Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
  • Self-reported change in body weight >5 kg within 3 months before Screening.
  • Have prior or planned surgical or non-surgical treatment for obesity.
  • Have or plan to have endoscopic and/or device-based therapy for obesity.
  • Have obesity induced by other endocrine disorders.
  • Impaired renal function at Screening
  • Chronic malabsorption

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 71 centers
  • ACCOMPLISH-1 Research Site — Birmingham
  • ACCOMPLISH-1 Research Site — Birmingham
  • ACCOMPLISH-1 Research Site — Phoenix
  • ACCOMPLISH-1 Research Site — Sun City West
  • ACCOMPLISH-1 Research Site — Tucson
  • ACCOMPLISH-1 Research Site — Escondido
  • ACCOMPLISH-1 Research Site — Gardena
  • ACCOMPLISH-1 Research Site — La Jolla
  • … and 63 more centers

Identifiers

NCT: NCT07654361 · GSBR-1290-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗