RecruitingPhase 2NCT07098663

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


Sponsor

Mankind Pharma Limited

Enrollment

68 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called MKP10241 to evaluate how food affects its absorption, and whether it is safe and effective for healthy people, people with obesity, and people with type 2 diabetes. The study takes place in a clinical research unit where participants stay for observation. **You may be eligible if...** - You are aged 18–60 - (Part 1): You are healthy with a normal BMI (18–30) and normal fasting blood sugar - (Part 2): You are healthy with obesity (BMI ≥32) and normal fasting blood sugar - (Part 3): You have type 2 diabetes managed by diet alone or stable metformin - You are a non-smoker or very light social smoker - You are willing to stay at the research unit and follow all restrictions **You may NOT be eligible if...** - You have liver, kidney, or significant blood abnormalities - You have a history of non-fever-related seizures - You have had major surgery in the past 60 months or plan surgery during the study - You have any history of malignant cancer (with minor exceptions) - You test positive for HIV, hepatitis B, or hepatitis C - You are pregnant or planning to become pregnant - You have had significant weight changes (±10%) in the past 3 months - You are currently taking medications other than paracetamol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMKP10241

Oral liquid suspension of unit dose strength 6.6 mg/mL

DRUGPlacebo

Oral liquid suspension matched in appearance to MKP10241 at dosage strengths


Locations(1)

Veritus Research

Bayswater, Victoria, Australia

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NCT07098663


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