Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Conditions

• Obesity With Diabetes
• Overweight With Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• KAI-9531 — DRUG
  SC Injection
• Placebo — DRUG
  SC Injection

Study Details

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Key Dates

Start date

Jan 12, 2026

Status verified

Jun 2026

Primary completion

Mar 27, 2028

Completion

Apr 24, 2028

Study Design

Enrollment

1,700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: KAI-9531: Dose 1
  Participants will receive Dose 1 of KAI-9531 once weekly.
• Experimental: KAI-9531: Dose 2
  Participants will receive Dose 2 of KAI-9531 once weekly.
• Experimental: KAI-9531: Dose 3
  Participants will receive Dose 3 of KAI-9531 once weekly.
• Experimental: KAI-9531: Dose 4
  Participants will receive Dose 4 of KAI-9531 once weekly.
• Placebo Comparator: Placebo
  Participants will receive placebo matched to KAI-9531 once weekly.

Primary Outcome Measure

Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [ Time Frame: Baseline, Week 76 ]

Central Contacts

• Kailera Therapeutics, Inc.
  781-317-0291
  [email protected]

Locations (34)

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