MKP10241 for Obesity and Type 2 Diabetes

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

Recruiting Phase 2 Interventional Study
Type 2 Diabetes Mellitus (T2DM) Food Effect Safety and Tolerability Obesity
Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
68 (estimated)
Sponsor
Mankind Pharma Limited · Industry
Who this trial is looking for

This trial is looking for healthy and obese adults, with or without type 2 diabetes, to test the effects of a new treatment called MKP10241. Participants will take the medication or a placebo daily for several weeks and attend regular follow-up visits.

Are You a Good Fit for This Trial?
Must be taking Metformin
Rules you out Type 1 diabetesRecent bariatric surgery

You may be able to join if

  • I am between 18 to 60 years old
  • I am healthy according to the investigator
  • I have a BMI of 32 or higher
  • I can give informed consent
  • I am a non-smoker or a social smoker
  • I am willing to avoid alcohol for 48 hours before dosing
  • I am willing to follow study rules and be confined at the research unit
  • I have type 2 diabetes managed by diet and exercise or a stable dose of Metformin (for at least 2 months)

You may not be able to join if

  • I have significant blood or liver problems
  • I have kidney problems
  • I have had a positive test for COVID-19
  • I have a history of seizures
  • I have had major surgery in the last 60 days
  • I am pregnant or plan to become pregnant
  • I have used certain drugs or medications in the last month
  • I have had significant weight change in the last 3 months

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion criteria * Male or female participants between 18 to 60 years of age * Considered healthy by the Investigator. Part 1: BMI of 18 to 30 kg/m2, and weight being not less than 50 kg. Part 2/3: BMI of ≥32 kg/m2 * Part 1/2: Fasting plasma glucose (FPG) between 3.9 mmol/L and 6.1 mmol/L. Part 3…
Contacts

Mohammad M Ahsan, B. Pharm, M.Sc

+91 124 2873900

muneeb.ahsan@mankindpharma.com

CONTACT

Santosh Kumar Rai, MSc, PhD

+91 124 2873900

santosh.rai@mankindpharma.com

CONTACT