Actively Recruiting
Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
Led by Mankind Pharma Limited · Updated on 2025-09-29
68
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
M
Mankind Pharma Limited
Lead Sponsor
E
Emerald Clinical Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants between 18 to 60 years of age
- Healthy participants with Body Mass Index (BMI) 18 to 30 kg/m2 and weight not less than 50 kg for Part 1
- Obese participants with BMI of 32 kg/m2 or higher for Parts 2 and 3
- Fasting plasma glucose between 3.9 mmol/L and 6.1 mmol/L for Parts 1 and 2
- Fasting plasma glucose between 6.94 mmol/L and 14.43 mmol/L for Part 3
- Nonsmoker or social smoker (not more than 5 cigarettes per day in the last 3 months)
- Able to abstain from alcohol from 48 hours before dosing to end of study
- Female participants of nonchildbearing potential or using effective contraception
- Male participants who are sexually active must use condoms or be surgically sterile; female partners of childbearing potential must use contraception
- Capable of giving signed informed consent
- Willing and able to follow study restrictions and stay at the clinical research unit
- Participants with diagnosed type 2 diabetes mellitus managed by diet and exercise or stable metformin use for 2 months (Part 3)
You will not qualify if you...
- Clinically significant blood abnormalities at screening
- Liver impairment with elevated liver enzymes or abnormal lab values
- Kidney impairment assessed by eGFR below 80 mL/min/1.73m2
- Positive test for SARS-CoV-2
- History of non-febrile seizures
- Positive pregnancy test at screening or admission
- Major surgery within 60 days prior or planned during the study
- History of malignant disease except certain skin or cervical cancers
- Allergy or hypersensitivity to MKP10241 or its components
- Any other condition judged unsuitable by investigator
- History or evidence of clinically significant disease
- Prior or planned bariatric surgery or ileal resection
- Substance use disorders or alcohol abuse in past 12 months
- Positive drug abuse test at screening or admission
- Use of live vaccines within 14 days prior to dosing
- Use of medications other than paracetamol, including hormonal contraceptives
- Receipt of other investigational drugs within one month or five half-lives
- Abnormal ECG findings (QTcF over 450 ms males, 470 ms females)
- High blood pressure (systolic >140 mmHg or diastolic >90 mmHg)
- Positive tests for HIV, hepatitis B, hepatitis C, or syphilis
- Weight change of 10% or more within 3 months prior to screening
- Recent blood donation or loss exceeding 1 unit (450 mL) within 30 days prior
- Diagnosis of type 1 diabetes, maturity-onset diabetes of the young, or other diabetes types (Part 3 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
Research Team
M
Mohammad M Ahsan, B. Pharm, M.Sc
CONTACT
S
Santosh Kumar Rai, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here