NCT06019559

A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833

A Randomized, Placebo-Controlled, Double-Blind 13-Week Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 in Participants Who Are Obese

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Kallyope Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the safety and efficacy of K-757 alone and in combination with K-833 versus placebo in participants who are obese.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	K-757 120 mg BID and K-833 100 mg BID	K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22. K-833 was initiated at 100 mg once daily in the morning (QAM) and was titrated to the maintenance dose of 100 mg BID on Day 8. Both administered orally.
DRUG	K-757 120 mg BID and matching placebo to K-833	K-757 was titrated to the maintenance dose of 120 mg twice daily (BID) by Day 22. Both administered orally.
DRUG	Matching placebo to K-757 and matching placebo to K-833	Both administered orally.

Timeline

• Start date: 2023-09-15
• Primary completion: 2024-02-07
• Completion: 2024-02-19
• First posted: 2023-08-31
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study