NCT07098663

Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes

A Phase 2a, Double-blind, Randomized, Placebo-controlled, Study to Assess Food Effect, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of MKP10241 in Healthy and Obese Adult Participants, With and Without Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Mankind Pharma Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts. The main parameters it aims to answers are : 1. Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants? 2. Will multiple ascending doses of MKP10241 in obese participants with or without T2DM characterize changes in the plasma pharmacokinetic profile and pharmacodynamic effects? 3. What treatment emergent adverse events or discontinuation is experienced following single and multiple ascending doses of MKP10241 in healthy and obese participants with or without T2DM? This study will be compared against a placebo which is matched in appearance to MKP10241 at dosage strengths. Participants will: 1. Part 1: Take MKP10241 400 mg or Placebo on Day 1 and Day 8. Part 2: Take MKP10241 200 mg, 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 Part 3: Take MKP10241 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 2. Visit the clinical research unit for dose administration, admission or follow up. 3. Will be monitored by the Safety Monitoring Committee.

Conditions

• Type 2 Diabetes Mellitus (T2DM)
• Food Effect
• Safety and Tolerability
• Obesity

Interventions

Type	Name	Description
DRUG	MKP10241	Oral liquid suspension of unit dose strength 6.6 mg/mL
DRUG	Placebo	Oral liquid suspension matched in appearance to MKP10241 at dosage strengths

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-01-19
• Completion: 2026-04-17
• First posted: 2025-08-01
• Last updated: 2025-09-29

Locations

1 site across 1 country: Australia