MKP10241 for food effects, safety, blood sugar control, and weight management in adults with and without type 2 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
This study will test whether the experimental pill MKP10241 is safe, how food affects its levels in the body, and whether it helps control blood sugar and weight in obese adults with and without type 2 diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Mankind Pharma Limited Industry-sponsored |
| Locations | 1 site (Bayswater, Victoria) |
| Trial ID | NCT07098663 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized, placebo-controlled interventional study is conducted in three parts to characterize single-dose food effects and multiple ascending doses of MKP10241. Part 1 compares PK after single 400 mg doses with and without food in healthy participants, while Parts 2 and 3 administer daily doses (200 mg, 300 mg, 400 mg cohorts) to obese participants with and without type 2 diabetes to measure PK, PD, and safety. Participants are randomized to MKP10241 or matched placebo and undergo serial blood sampling for pharmacokinetics and pharmacodynamics, along with safety monitoring for treatment-emergent adverse events and discontinuations. The trial uses predefined glucose and BMI inclusion criteria and excludes smokers above a light-use threshold and those unable to follow contraception or alcohol restrictions.
Who should consider this trial
Good fit: Adults aged 18–60 who meet the BMI and fasting plasma glucose ranges for the specific study part (healthy BMI 18–30 kg/m2 for fOOD-effect arm; BMI ≥32 kg/m2 for obese arms) and who meet other screening criteria are ideal candidates.
Not a fit: People with type 1 diabetes, those outside the study age or BMI/FPG ranges, pregnant or breastfeeding individuals, or those with contraindicated health conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, MKP10241 could offer a new oral option with predictable food-related dosing, acceptable safety, and benefits for blood sugar control and weight in obese adults with or without type 2 diabetes.
How similar studies have performed: Other drugs targeting metabolic and weight pathways have shown benefit for glucose and weight, but MKP10241 itself is experimental with limited prior clinical data reported.
Eligibility criteria
Show full inclusion / exclusion 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: FPG greater than or equal to 6.94 mmol/L and less than or equal to 14.43 mmol/L * A nonsmoker/social smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the 3 months prior to Screening. * Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing to the End of Study Visit. * Female participants must be of nonchildbearing potential or, if of childbearing potential, must agree to use 1 form of highly effective contraceptive method, plus an additional barrier method of contraception between signing consent * Male participants who are sexually active must use a condom from Screening until at least 90 days after the last dose of study intervention (or be surgically sterile. Female partners of childbearing potential must use a highly effective method of contraception. * Capable of giving signed Informed Consent * Willing and able to adhere to study restrictions and to be confined at the CRU. * Part 3: Participants with an established diagnosis of type 2 diabetes mellitus * Part 3: Participants; type 2 diabetes mellitus must be managed by diet and exercise alone or by stable dose of metformin (for ≥2 months); the use of other antidiabetic therapies is prohibited Exclusion criteria * Clinically significant haematological findings at Screening. * Hepatic impairment including aspartate aminotransferase (AST), alanine transaminase (ALT), or alkaline phosphatase ≥1.5 times upper limit of normal (ULN), total bilirubin ≥2.0 times ULN, albumin ≤3.0 g/L, serum amylase or lipase ≥1.5 times ULN at Screening. * Renal impairment, such as creatinine ≥ULN, estimated glomerular filtration rate (eGFR) of ≤80 mL/minute/1.73m2 in adults, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula * Positive polymerase chain reaction (PCR) test for severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2) * A history of non-febrile seizures. * Positive pregnancy test result at Screening or on admission to the CRU, * Any major surgery within 60 days prior to Screening, or planned major surgery during the study. * Any history of malignant disease excluding surgically resected skin and in-situ cervical squamous cell or basal cell carcinoma. * Suspected hypersensitivity to MKP10241 and any components of MKP10241 liquid suspension * Any other condition which makes the participant unsuitable for study participation as judged by the Investigator or designee. * Participant has any history or evidence of any clinically significant disease * Prior or planned (during study period) bariatric surgery (e.g. gastric bands, gastroplasty Roux-e-Y gastric bypass) or ileal resection. * Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) substance use disorders and alcohol abuse within 12 months prior to Screening and/or positive alcohol breath test at Screening or admission. * Positive result for drugs of abuse at Screening or admission. * Use of live attenuated vaccines within 14 days prior to dosing * The use of medications (other than paracetamol), including hormonal contraceptives * Receipt of any other investigational medicinal product within one month or five half-lives (whichever is longer) prior to dosing. * Clinically significant ECG findings: QTcF value ≥450 ms for males or ≥470 ms for females at Screening or Day -1 * Participants with a mean systolic blood pressure \>140 mmHg, mean diastolic blood pressure \>90 mmHg at Screening. * Positive blood screen for human immunodeficiency virus antibody (HIV), hepatitis B surface antigen (HBsAg), syphilis, hepatitis C virus (HCV). * Change in body weight of ≥ 10% within 3 months prior to the Screening visit. * Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products, plasma) or acute loss of blood during the 30 days prior to Screening. * Part 3: Type 1 diabetes mellitus, maturity-onset diabetes of the young, or other forms of diabetes.
Where this trial is running
Bayswater, Victoria
- Veritus Research — Bayswater, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Stephen Hall, MBBS, FRACP — Veritus Research
- Study coordinator: Mohammad M Ahsan, B. Pharm, M.Sc
- Email: muneeb.ahsan@mankindpharma.com
- Phone: +91 124 2873900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.