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KAI-4729

Phase 1

Overweight or Obesity | Small Molecules | Other |Kailera Therapeutics, Inc.|Trials Updated: Nov 9, 2026

KAI-4729 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

KAI-4729 clinical trials

KAI-4729 · 1 trial · 1 indication

Phase 1 1
NCT07924761A Study to Investigate the Effect of Injection Site and Ethnicity on KAI-4729 Pharmacokinetics in Non-Asian and Asian Participants Living With Obesity or OverweightOverweight or Obesity
NOT YET_RECRUITING60 Analytics
PHASE1NOT YET_RECRUITING
A Study to Investigate the Effect of Injection Site and Ethnicity on KAI-4729 Pharmacokinetics in Non-Asian and Asian Participants Living With Obesity or Overweight
Overweight or ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
Cmax of KAI-4729 in Healthy Non-Asian and Asian Participants
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
AUC0-t of KAI-4729 in Healthy Non-Asian and Asian Participants
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
AUC0-inf of KAI-4729 in Healthy Non-Asian and Asian Participants
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)

Secondary Endpoints

Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Day 1 to Day 99
Number of Participants Who Experience a Serious Adverse Event (SAE)
Day 1 to Day 99
Number of Participants Who Experience Antidrug Antibodies (ADAs) to KAI-4729
Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Upper Arm Injection SiteEXPERIMENTALParticipants will receive KAI-4729 as a single SC injection into the upper arm on Day 1 of either Treatment Period 1, 2, or 3.
Abdomen Injection SiteEXPERIMENTALParticipants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of either Treatment Period 1, 2, or 3.
Thigh Injection SiteEXPERIMENTALParticipants will receive KAI-4729 as a single SC injection into the thigh on Day 1 of either Treatment Period 1, 2, or 3.
Abdomen Injection Site (Asian Participants)EXPERIMENTALAsian participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of Treatment Period 1.

Interventions

NameTypeDescription
KAI-4729DRUGSC injection
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Have a body mass index (BMI) ≥25 and ≤40 kilograms per square meter at screening (Days -28 to -2) and on Day -1 of the first Treatment Period * Non-Asian Participants Only: Be of non-Asian descent and not identify as being of East Asian origin * Asian Participants Only: Be...

Countries:United States
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Recent Changes (Last 90 Days)

LOWNov 9, 2026NCT07924761NEW_TRIAL: changed
LOWNov 9, 2026NCT07924761NEW_TRIAL: changed