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KAI-9531

DRUG8 trials

Sponsors

Kailera Therapeutics Inc., Kailera

Conditions

Healthy VolunteersObesityObesity With DiabetesOverweightOverweight With Diabetes

Phase 1

A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices
CompletedNCT07044401
KaileraHealthy Volunteers
Start: 2025-07-14End: 2025-11-13Updated: 2025-12-05

Phase 2

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
RecruitingNCT07458269
KaileraObesity
Start: 2026-03-04End: 2027-06-01Target: 250Updated: 2026-04-20

Phase 3

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
RecruitingNCT07284901
KaileraObesity With Diabetes, Overweight With Diabetes
Start: 2026-01-12End: 2028-04-24Target: 1700Updated: 2026-05-20
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
RecruitingNCT07284979
KaileraObesity
Start: 2025-12-30End: 2028-04-17Target: 1200Updated: 2026-04-30
Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
RecruitingNCT07284875
KaileraObesity, Overweight
Start: 2025-12-18End: 2028-03-27Target: 1800Updated: 2026-05-08
A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living with Obesity Who Do Not Have Diabetes
Not yet recruitingCTIS2025-523511-11-00
Kailera Therapeutics Inc.Obesity
Target: 126Updated: 2026-04-29
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight and Diabetes
Not yet recruitingCTIS2025-523510-87-00
Kailera Therapeutics Inc.Obesity
Target: 37Updated: 2026-05-04
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight with Weight-Related Comorbidities Who Do Not Have Diabetes
Not yet recruitingCTIS2025-523486-17-00
Kailera Therapeutics Inc.Obesity
Target: 79Updated: 2026-05-05