Study S003235

A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of a Low-Fat Meal and Evening Dosing on the Pharmacokinetics of KAI-7535 in Healthy Participants Living With Obesity or Overweight

ClinicalTrials.gov record

Registration

Registration: NCT07294898
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 18
Start: 2025-12-15
Primary completion: 2026-01-26
Lead sponsor: Kailera
Conditions: Obesity; Overweight
Interventions: DRUG:KAI-7535
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Time to Maximum Observed Concentration (Tmax) of KAI-7535 [Pre-dose and up to 60 hours post-dose]
Maximum Observed Concentration (Cmax) of KAI-7535 [Pre-dose and up to 60 hours post-dose]
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535 [Pre-dose and up to 60 hours post-dose]
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535 [Pre-dose and up to 60 hours post-dose]

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