A Phase 1 interventional study of KAI-7535 in Obesity and Overweight, sponsored by Kailera. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Kailera · Phase 1, Interventional, and Treatment
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 18 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Kailera is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Participants will receive KAI-7535 in the morning following a meal on dosing days.
Drug: KAI-7535
Participants will receive KAI-7535 in the morning following an overnight fast on dosing days.
Drug: KAI-7535
Participants will receive KAI-7535 in the evening on dosing days.
Drug: KAI-7535
Oral tablets.
Time to Maximum Observed Concentration (Tmax) of KAI-7535
Time frame: Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535
Time frame: 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
Time frame: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535
Time frame: Pre-dose and up to 60 hours post-dose
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 up to Day 12
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Kailera