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

Conditions

• Obesity, Overweight, or Chronic Weight Management

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2027

Completion

Apr 30, 2029

Study Design

Enrollment

3,600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Participants will receive aleniglipron administered orally.
• Experimental: Arm 2
  Participants will receive aleniglipron administered orally.
• Experimental: Arm 3
  Participants will receive aleniglipron administered orally.
• Experimental: Arm 4
  Participants will receive placebo administered orally.

Primary Outcome Measure

Percent change in body weight from Baseline [ Time Frame: Baseline and Week 76 ]

Central Contacts

• Medical Director
  1-650-457-1959
  [email protected]

Locations (71)

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