Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emerald Clinical Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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 :
This study will be compared against a placebo which is matched in appearance to MKP10241 at dosage strengths.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1- MKP10241 400 mg | Experimental | Participants will receive MKP10241 400 mg on Day 1 and Day 8. |
|
| Part 1 - Placebo | Placebo Comparator | Participants will receive placebo 400 mg on Day 1 and Day 8. |
|
| 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 |
|
| Part 2 - Placebo | Placebo Comparator | Participants will receive placebo daily from Day 1 to Day 28 |
|
| 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 |
|
| Part 3 - Placebo | Placebo Comparator | Participants will receive placebo daily from Day 1 to Day 28 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MKP10241 | Drug | Oral liquid suspension of unit dose strength 6.6 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2 - Impact of multiple doses of MKP10241 administered to obese participants without T2DM on participant Hunger and Satiety Visual Analogue Scale | Will be checked for change in participant Hunger and Satiety VAS score on Day 14 and Day 28 from baseline Participants will be asked to make a mark on a scale to indicate their hunger levels. The distance along line where the participant made their mark will be used as the measure. The distance in mm the participant marks on the scale will be used as a quantitative measure.Shorter means not hungry at all and higher means more hungry. |
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Hall, MBBS, FRACP | Veritus Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Recruiting | Bayswater | Victoria | 3153 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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
Not provided
|
| Placebo | Drug | Oral liquid suspension matched in appearance to MKP10241 at dosage strengths |
|
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 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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 | Baseline to Day 28 |
| 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) | Baseline to Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacodynamic parameters: Oral Glucose Tolerance Test | From screening visit to day 29 |
| 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. | Day 1, 7, 14, 21 and 28 |
| 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. | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2 , 28 and 29 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants with T2DM. | Pharmacodynamic parameters - Total cholesterol levels | At Baseline,Day 1, 7, 14, 21 and Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants. | Pharmacodynamic parameters - Lipase | At baseline and Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacodynamic parameters - Total amylin | At baseline and Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacodynamic parameters - C-Reactive Protein | At baseline and Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacodynamic parameters - Hepatic transaminases | At baseline and Day 28 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacodynamic parameters - Blood Pressure | Baseline to Day 28 |
| 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. | Day 1, 7, 14, 21 and 28. |
| 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. | Day 1,2,28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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 | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacodynamic parameters - Total cholesterol levels | At Baseline,Day 1, 7, 14, 21 and Day 28 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacodynamic parameters - total amylin | At baseline and Day 28 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM | Pharmacodynamic parameters - C-Reactive Protein | At baseline and Day 28 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacodynamic parameters - Hepatic transaminases | At baseline and Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacokinetic parameter evaluation - Maximum concentration (Cmax) | 35 days |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacokinetic parameter evaluation - Total Clearance of the drug | 35 days |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacokinetic parameter evaluation - Time to maximum concentration(Tmax) | 35 days |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants | Pharmacokinetic parameter evaluation -Elimination Half life (t1/2) | 35 days |
| 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) | 35 days |
| 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) | 35 days |
| 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 | 35 days |
| 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) | 35 days |
| 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) | 35 days |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacokinetic parameter evaluation - Maximum concentration (Cmax) | 35 days |
| 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 | 35 days |
| 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) | 35 days |
| 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) | 35 days |
| 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) | 35 days |
| 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) | 35 days |
| 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 | 35 days |
| 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) | 35 days |
| 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) | 35 days |
| 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 | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2,28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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. | Day 1, 2, 28 and 29 |
| 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 | Day 1, 2, 28 and 29 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacodynamic parameters - Lipase | At baseline and Day 28 |
| Part 2 - Pharmacokinetics and Pharmacodynamics of MKP10241 following multiple doses in obese adult participants with T2DM. | Pharmacodynamic parameters - Triglyceride | At Baseline,Day 1, 7, 14, 21 and Day 28 |
| Part 3 - Pharmacokinetic and Pharmacodynamic effects of MKP10241 following multiple doses administration in obese adult participants with T2DM. | Pharmacodynamic parameters - Triglyceride | At Baseline,Day 1, 7, 14, 21 and Day 28 |
| 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 | Visceral fats will be measured by MRI-PDFF. The change in magnetic resonance derived proton density visceral fat fraction i.e. percentage of fat in the whole abdominal region will be measured. | 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. | Will be checked for change in participant Hunger and Satiety VAS score on Day 14 and Day 28 from baseline(Day- 1) Participants will be asked to make a mark on a scale to indicate their hunger levels. The distance along line where the participant made their mark will be used as the measure. The distance in mm the participant marks on the scale will be used as a quantitative measure. Shorter means not hungry at all and higher means more hungry. | Day 14 and Day 28 from baseline. |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |