NCT05900531

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers

A 28-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kallyope Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 alone, in combination with sitagliptin, or in combination with K-833.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	K-757	administered orally
DRUG	K-757 and open-label sitagliptin	both administered orally
DRUG	Matching placebo to K-757	administered orally
DRUG	Matching placebo to K-757 and matching placebo to K-833	both administered orally
DRUG	K-757 and K-833	both administered orally
DRUG	Matching placebo to K-757, open-label sitagliptin	both administered orally

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-05-03
• Completion: 2023-05-31
• First posted: 2023-06-12
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study