A Study to Investigate the Effect of a Low-fat Meal and Evening Dosing on KAI-7535 in Participants Living With Obesity or Overweight
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
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
Started Dec 2025
Shorter than P25 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2026
CompletedJanuary 29, 2026
January 1, 2026
1 month
December 8, 2025
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (1)
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Day 1 up to Day 12
Study Arms (3)
KAI-7535: Morning Dosing, Fed
EXPERIMENTALParticipants will receive KAI-7535 in the morning following a meal on dosing days.
KAI-7535: Morning Dosing, Fasted
EXPERIMENTALParticipants will receive KAI-7535 in the morning following an overnight fast on dosing days.
KAI-7535: Evening Dosing
EXPERIMENTALParticipants will receive KAI-7535 in the evening on dosing days.
Interventions
Oral tablets.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) ≥25.0 and ≤40.0 kg/m\^2.
- Medically healthy, as determined by prestudy medical history, and without clinically significant (CS) abnormalities.
You may not qualify if:
- Known hypersensitivity to study treatment or any study treatment ingredients.
- History or presence of CS cardiovascular, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaileralead
Study Sites (1)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 19, 2025
Study Start
December 15, 2025
Primary Completion
January 26, 2026
Study Completion
January 26, 2026
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share