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

NCT07098663 | Recruiting Phase 2 DMC

• 1 other identifier: MKP10241-201
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants?
2. 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. 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?
4. 4.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
5. 5.Visit the clinical research unit for dose administration, admission or follow up.
6. 6.Will be monitored by the Safety Monitoring Committee.

Conditions

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

Keywords

MKP10241; Safety and tolerability of MKP10241; Pharmacokinetics and Pharmacodynamics of MKP10241; Management of T2DM with MKP10241; Management of Obesity with MKP10241

Outcome Measures

Primary Outcomes (11)

• Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax)

  Maximum concentration (Cmax) following a single 400 mg dose of MKP10241 under fasting and fed condition

  18 days

• Part 1 - Food effect of single dose of MKP10241 on Apparent total clearance of drug (CL/F)

  Total Clearance of the drug following a single 400 mg dose of MKP10241 under fasting and fed conditions

  18 days

• Part 1 - Food effect of single dose of MKP10241 on Time to maximum concentration (Tmax)

  Time to maximum concentration (Tmax) following a single 400 mg dose of MKP10241 under fasting and fed condition

  18 days

• Part 1 - Food effect of single dose of MKP10241 on elimination half life (t1/2 )

  Elimination Half life (t1/2) following a single 400 mg dose of MKP10241 under fasting and fed conditions

  18 days

• Part 1 - Food effect of single dose of MKP10241 on lag time (Tlag)

  Delay between the time of dosing and the time of appearance of the drug concentration in sampling (Tlag) for single 400 mg dose of MKP10241 under fasting and fed conditions

  18 days

• Part 1 - Food effect of single dose of MKP10241 on Apparent Volume of distribution of drug (V/F)

  Apparent Volume of distribution of drug(V/F) following a single 400 mg dose of MKP10241 under fasting and conditions

  18 days

• Part 1 - Food effect of single dose of MKP10241 on Area under the curve from time 0 to 24hrs - AUC (0-24h)

  Area under the plasma concentration time curve from time 0 to 24hrs - AUC(0-24h) following a single 400 mgMKP10241 under fasting and fed conditions

  18 days

• Part 1 - Food effect of single dose of MKP10241 on AUC(0-last)

  Area under the curve from time 0 to the last value above the limit of quantification AUC(0-last) following a single dose of MKP10241 under fasting and fed conditions

  18 days

• Part 1 - Food effect of single dose of MKP10241 on AUC(0-inf)

  Area under the curve from time 0 extrapolated to infinity AUC(0-inf) following a single 400 mg dose of MKP10241 fasting and fed conditions

  18 days

• Part 2 - To evaluate the incidence of treatment emergent adverse events and participant tolerance of MKP10241 following multiple doses in obese participants

  It will be measured based on the Treatment emergent adverse events which includes significant changes in examination, blood and urine analysis, vital signs and ECG etc. Treatment discontinuation for any reason considered as intolerant.

  35 days

• Part 3 - To evaluate the incidence of treatment emergent adverse events and participant tolerance of MKP10241 following multiple doses in obese participants with T2DM.

  It will be measured based on the Treatment emergent adverse events which includes significant changes in examination, blood and urine analysis, vital signs and ECG etc. Treatment discontinuation for any reason considered as intolerant.

  35 days

Secondary Outcomes (59)

• Part 1 - To evaluate the incidence of treatment emergent adverse events and of MKP10241 following a single dose administered orally under fasting and fed conditions.

  18 days

• Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants

  Baseline to Day 28

• Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants

  Baseline to Day 28

• Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants

  Baseline to Day 28

• Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants.

  Baseline to Day 28

Other Outcomes (3)

• Part 2 - Impact of multiple doses of MKP10241 administered to obese participants without T2DM on participant Hunger and Satiety Visual Analogue Scale

  Day 14 and Day 28 from baseline

• Part 2 - Impact of multiple doses of MKP10241 administered to obese participants without T2DM on participant Visceral fat

  Baseline to Day 32

• Part 3 - Impact of multiple doses of MKP10241 administered to obese participants with T2DM on participant Hunger levels and Satiety Visual Analogue Scale.

  Day 14 and Day 28 from baseline.

Study Arms (6)

Part 1- MKP10241 400 mg

EXPERIMENTAL

Participants will receive MKP10241 400 mg on Day 1 and Day 8.

Drug: MKP10241

Part 1 - Placebo

PLACEBO COMPARATOR

Participants will receive placebo 400 mg on Day 1 and Day 8.

Drug: Placebo

Part 2 - MKP10241 200 mg, 300 mg and 400 mg

EXPERIMENTAL

Participants will receive MKP10241 200 mg, 300 mg and 400 mg daily from Day 1 to Day 28

Drug: MKP10241

Part 2 - Placebo

PLACEBO COMPARATOR

Participants will receive placebo daily from Day 1 to Day 28

Drug: Placebo

Part 3 - MKP10241 300 mg and 400 mg

EXPERIMENTAL

Participants will receive MKP10241 300 mg and 400 mg daily from Day 1 to Day 28

Drug: MKP10241

Part 3 - Placebo

PLACEBO COMPARATOR

Participants will receive placebo daily from Day 1 to Day 28

Drug: Placebo

Interventions

MKP10241 DRUG

Oral liquid suspension of unit dose strength 6.6 mg/mL

Part 1- MKP10241 400 mg; Part 2 - MKP10241 200 mg, 300 mg and 400 mg; Part 3 - MKP10241 300 mg and 400 mg

Placebo DRUG

Oral liquid suspension matched in appearance to MKP10241 at dosage strengths

Part 1 - Placebo; Part 2 - Placebo; Part 3 - Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mankind Pharma Limited: lead
• Emerald Clinical Inc.: collaborator

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Hall, MBBS, FRACP

  Veritus Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad M Ahsan, B. Pharm, M.Sc

CONTACT

+91 124 2873900; muneeb.ahsan@mankindpharma.com

Santosh Kumar Rai, MSc, PhD

CONTACT

+91 124 2873900; santosh.rai@mankindpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part 1 of the study is Open Label but Part 2 and 3 is a double blind ,in which participants/care providers/investigators/outcomes assessors, etc are blinded to study intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 and Part 2 (Cohort 1) of the study will run in parallel. Part 3 will be a randomized, double-blind, placebo-controlled, Multiple ascending dose study.

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: August 1, 2025
• Study Start: August 12, 2025
• Primary Completion: January 19, 2026
• Study Completion: April 17, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)