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

NCT07098663 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-29

No results posted yet for this study

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. 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

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

Interventions

DRUG

MKP10241

Oral liquid suspension of unit dose strength 6.6 mg/mL

DRUG

Placebo

Oral liquid suspension matched in appearance to MKP10241 at dosage strengths

Sponsors & Collaborators

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • Mankind Pharma Limited

    lead INDUSTRY

Principal Investigators

  • Stephen Hall, MBBS, FRACP · Veritus Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-01-19
Completion
2026-04-17

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07098663 on ClinicalTrials.gov