NCT06305351

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes

A 42-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 And K-833 in Overweight/Obese Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Kallyope Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM)

Conditions

• Obesity
• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	K-757 and K-833 QD	Both administered orally once daily
DRUG	K-757 and K-833 BID	Both administered orally twice daily
DRUG	Matching placebo to K-757 and K-833 QD	Both administered orally once daily
DRUG	Matching placebo to K-757 and K-833 BID	Both administered orally twice daily

Timeline

• Start date: 2023-12-07
• Primary completion: 2024-05-15
• Completion: 2024-06-21
• First posted: 2024-03-12
• Last updated: 2024-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study