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AzTrials

Type 2 Diabetes Mellitus (T2DM)Phase 2NCT07098663

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

A Phase 2 study testing MKP10241 in people with Type 2 Diabetes Mellitus (T2DM) and Food Effect, run by Mankind Pharma Limited at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
MKP10241
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteAustralia
Study dates
12 Aug 2025to 17 Apr 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Australia1 site, 1 recruiting

  • Veritus Research

    Bayswater, Victoria, 3153

    Stephen Hall, MBBS,MD, 03 8736 1758 Or 0494 062 402, info@veritusresearch.com

    Recruiting

Other trials in Australia

About this study

Official title: 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

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?
Read more

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.
Being tested
MKP10241, Placebo
Keywords
MKP10241, Safety and tolerability of MKP10241, Pharmacokinetics and Pharmacodynamics of MKP10241, Management of T2DM with MKP10241, Management of Obesity with MKP10241
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MKP10241Drug

    Oral liquid suspension of unit dose strength 6.6 mg/mL

  • PlaceboDrug

    Oral liquid suspension matched in appearance to MKP10241 at dosage strengths

Study groups in NCT07098663
Study groupRoleWhat they receive
Part 1- MKP10241 400 mgExperimentalParticipants will receive MKP10241 400 mg on Day 1 and Day 8.
Receives: Drug: MKP10241
Part 1 - PlaceboPlacebo comparatorParticipants will receive placebo 400 mg on Day 1 and Day 8.
Receives: Drug: Placebo
Part 2 - MKP10241 200 mg, 300 mg and 400 mgExperimentalParticipants will receive MKP10241 200 mg, 300 mg and 400 mg daily from Day 1 to Day 28
Receives: Drug: MKP10241
Part 2 - PlaceboPlacebo comparatorParticipants will receive placebo daily from Day 1 to Day 28
Receives: Drug: Placebo
Part 3 - MKP10241 300 mg and 400 mgExperimentalParticipants will receive MKP10241 300 mg and 400 mg daily from Day 1 to Day 28
Receives: Drug: MKP10241
Part 3 - PlaceboPlacebo comparatorParticipants will receive placebo daily from Day 1 to Day 28
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 days

  2. 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

    Measured: 18 days

  3. 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

    Measured: 18 days

  4. 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

    Measured: 18 days

  5. 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

    Measured: 18 days

  6. 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

    Measured: 18 days

  7. 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

    Measured: 18 days

  8. 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

    Measured: 18 days

  9. 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

    Measured: 18 days

  10. 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.

    Measured: 35 days

  11. 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.

    Measured: 35 days

Secondary outcomes (59)

  1. 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.

    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.

    Measured: 18 days

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

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants the below will be measured:

    Change in Heart Rate in beats per minute

    Measured: Baseline to Day 28

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

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured:

    Change in body weight in kilograms

    Measured: Baseline to Day 28

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

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured:

    Change in BMI in kilograms per meter square

    Measured: Baseline to Day 28

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

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured:

    Change in mid-abdominal circumference in centimeters

    Measured: Baseline to Day 28

  6. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Heart rate in beats per minute

    Measured: Baseline to Day 28

  7. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured:

    Change in body weight in kilograms

    Measured: Baseline to Day 28

  8. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in the below will be measured:

    • Change in Body Mass index in kilogram per meter square

    Measured: Baseline to Day 28

  9. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants given in below will be measured:

    Change in mid-abdominal circumference in centimeters

    Measured: Baseline to Day 28

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

    Pharmacodynamic parameters - To evaluate surrogate markers of efficacy and mechanism of action in obese participants the below will be measured:

    Change in Blood Pressure in millimeters of mercury (mmHg)

    Measured: Baseline to Day 28

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

    Pharmacodynamic parameters: Oral Glucose Tolerance Test

    Measured: From screening visit to day 29

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

    Pharmacodynamic parameters - Fasting plasma glucose pre-dose on Days 1, 7, 14, 21 and 28.

    Measured: Day 1, 7, 14, 21 and 28

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

    Pharmacodynamic parameters -

    Total insulin levels pre-dose, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4 hours, 6.0 hours, 8.0 hours, and Day 1, 28 and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  14. Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants with T2DM.

    Pharmacodynamic parameters -

    GLP-1 (active and total) levels pre-dose, 0.25 hours, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, and 12 hours on Day 1, 28 and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2 , 28 and 29

  15. Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants with T2DM.

    Pharmacodynamic parameters - Total cholesterol levels

    Measured: At Baseline,Day 1, 7, 14, 21 and Day 28

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

    Pharmacodynamic parameters - Lipase

    Measured: At baseline and Day 28

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

    Pharmacodynamic parameters - Total amylin

    Measured: At baseline and Day 28

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

    Pharmacodynamic parameters - C-Reactive Protein

    Measured: At baseline and Day 28

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

    Pharmacodynamic parameters - Hepatic transaminases

    Measured: At baseline and Day 28

  20. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Blood Pressure

    Measured: Baseline to Day 28

  21. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Fasting plasma glucose pre-dose on Days 1, 7, 14, 21 and 28.

    Measured: Day 1, 7, 14, 21 and 28.

  22. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Total Insulin pre-dose, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1,2,28 and 29

  23. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Glucagon levels pre-dose, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hour, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  24. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - GLP 1 pre-dose, 0.25 hours, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  25. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM

    Pharmacodynamic parameters - C peptide pre-dose, 0.25 hours, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0hours, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  26. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Total Glucose-dependent Insulinotropic Polypeptide pre-dose, 0.25 hours, 0.5 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  27. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - total amount of Peptide YY (PYY) pre-dose, 0.25 hours, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29

    Measured: Day 1, 2, 28 and 29

  28. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Leptin pre-dose, 0.25 hours, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  29. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Total cholesterol levels

    Measured: At Baseline,Day 1, 7, 14, 21 and Day 28

  30. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - total amylin

    Measured: At baseline and Day 28

  31. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM

    Pharmacodynamic parameters - C-Reactive Protein

    Measured: At baseline and Day 28

  32. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Hepatic transaminases

    Measured: At baseline and Day 28

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

    Pharmacokinetic parameter evaluation - Maximum concentration (Cmax)

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Total Clearance of the drug

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Time to maximum concentration(Tmax)

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation -Elimination Half life (t1/2)

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Delay between the time of dosing and the time of appearance of the concentration in sampling (Tlag)

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Apparent Volume of distribution of drug(V/F)

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Area under the plasma concentration time curve from time 0 to 24hr

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Area under the curve from time 0 to the last value above the limit of quantification AUC(0-last)

    Measured: 35 days

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

    Pharmacokinetic parameter evaluation - Area under the curve from time 0 extrapolated to infinity AUC(0-inf)

    Measured: 35 days

  42. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Maximum concentration (Cmax)

    Measured: 35 days

  43. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Total Clearance of the drug

    Measured: 35 days

  44. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Time to maximum concentration(Tmax)

    Measured: 35 days

  45. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Elimination Half life (t1/2)

    Measured: 35 days

  46. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Delay between the time of dosing and the time of appearance of the concentration in sampling (Tlag)

    Measured: 35 days

  47. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Apparent Volume of distribution of drug(V/F)

    Measured: 35 days

  48. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Area under the plasma concentration time curve from time 0 to 24hours

    Measured: 35 days

  49. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacokinetic parameter evaluation - Area under the curve from time 0 to the last value above the limit of quantification AUC(0-last)

    Measured: 35 days

  50. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM

    Pharmacokinetic parameter evaluation - Area under the curve from time 0 extrapolated to infinity AUC(0-inf)

    Measured: 35 days

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

    Pharmacodynamic parameter - Glucagon levels pre-dose, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours and 12 hours on Day 1 and 28 and 24 hours post-dose on Day 2 and 29

    Measured: Day 1, 2, 28 and 29

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

    Pharmacodynamic parameters - C-peptide levels pre-dose, 0.25 hours, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hour, 4.0 hour, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

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

    Pharmacodynamic parameters - total GIP levels pre-dose, 0.25 hours, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hours, 4.0 hour, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2,28 and 29

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

    Pharmacodynamic parameters - total PYY levels pre-dose, 0.25 hours, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hour, 4.0 hour, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

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

    Pharmacodynamic parameters - leptin levels pre-dose, 0.25 hours, 0.5 hours, 1.0 hour, 2.0 hours, 3.0 hours, 4.0 hour, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29.

    Measured: Day 1, 2, 28 and 29

  56. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - glycated hemoglobin HbA1c pre-dose, 0.25 hours, 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 12 hours on Day 1 and 28, and 24 hours post-dose on Day 2 and 29

    Measured: Day 1, 2, 28 and 29

  57. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Lipase

    Measured: At baseline and Day 28

  58. Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants with T2DM.

    Pharmacodynamic parameters - Triglyceride

    Measured: At Baseline,Day 1, 7, 14, 21 and Day 28

  59. Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM.

    Pharmacodynamic parameters - Triglyceride

    Measured: At Baseline,Day 1, 7, 14, 21 and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start12 Aug 2025
  3. Primary completion19 Jan 2026 (estimated)
  4. Study completion17 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098663
Sponsor's protocol ID
MKP10241-201
Status last verified
Sep 2025
First submitted
15 Jun 2025
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MKP10241 in people with Type 2 Diabetes Mellitus (T2DM) and Food Effect, run by Mankind Pharma Limited at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohammad M Ahsan, B. Pharm, M.Sc (+91 124 2873900, muneeb.ahsan@mankindpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax) (time frame: 18 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07098663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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