A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

Conditions

• Obesity, Overweight, or Chronic Weight Management, T2DM

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

1,100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Participants will receive aleniglipron administered orally.
• Experimental: Cohort 2
  Participants will receive aleniglipron administered orally.
• Experimental: Cohort 3
  Participants will receive aleniglipron administered orally.
• Placebo Comparator: Cohort 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 (74)

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