Phase 2 Type 2 Diabetes Trial, Recruiting NCT07098663 Sponsor: Mankind Pharma Limited Condition: Type 2 Diabetes
Back to Type 2 Diabetes

Phase 2 Type 2 Diabetes Trial, Recruiting

NCT07098663
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 60 years old (male or female)
  • You are considered generally healthy by the study doctor
  • Depending on which part of the trial you join: you have a body weight in the normal-to-healthy range (Parts 1), are significantly overweight (Parts 2 and 3), or have been diagnosed with type 2 diabetes (Part 3)
  • Your fasting blood sugar level falls within the range required for the part of the trial you are joining (confirm with trial site)
  • You do not smoke, or smoke very little (no more than 5 cigarettes or equivalent per day in the past 3 months)
  • You are able to avoid alcohol completely for 48 hours before taking the study drug and until your final study visit
  • If you are a woman who could become pregnant, you agree to use one highly effective form of contraception plus an additional barrier method throughout the study
  • If you are a man who is sexually active, you agree to use a condom from the start of the study until at least 90 days after your last dose (or you have had a surgical procedure making you unable to father children), and any female partner who could become pregnant also uses a highly effective contraceptive
  • You are able and willing to give signed consent to take part
  • You are willing and able to follow all study rules, including staying at the study clinic when required
  • For Part 3 only: you have an established diagnosis of type 2 diabetes managed by diet and exercise alone, or by a stable dose of metformin for at least 2 months

Who may not be able to join:

  • You have significant abnormalities in blood count results found at screening (confirm with trial site)
  • You have liver problems, including abnormal liver enzyme or related blood test results above certain levels at screening
  • You have kidney problems, including reduced kidney function below a certain level at screening
  • You have tested positive for COVID-19 (SARS-CoV-2)
  • You have a history of seizures that were not caused by a fever
  • You have a positive pregnancy test at screening or when admitted to the clinic
  • You have had major surgery within the past 60 days, or have major surgery planned during the study
  • You have a history of cancer, except for certain skin cancers that have been fully removed by surgery
  • You have a known or suspected allergy to the study drug or any of its ingredients
  • You have any other condition that the study doctor feels makes you unsuitable for the study
  • You have a history or current evidence of any significant illness or medical condition
  • You have previously had, or are planning to have, weight-loss surgery (such as gastric bypass or gastric band) or removal of part of the intestine
  • You have had a substance use disorder or alcohol misuse in the past 12 months, or you test positive for alcohol at screening or when admitted to the clinic
  • You test positive for recreational drugs at screening or when admitted to the clinic
  • You have received a live vaccine within 14 days before taking the study drug
  • You are currently taking any medications other than paracetamol, including hormonal contraceptives
  • You have taken part in another clinical trial or received an investigational drug within the past month or five half-lives of that drug (whichever is longer)
  • Your heart's electrical activity shows certain abnormalities on an ECG at screening (confirm with trial site)
  • Your blood pressure is above 140/90 mmHg at screening
  • You test positive for HIV, hepatitis B, hepatitis C, or syphilis
  • Your body weight has changed by 10% or more in the 3 months before screening
  • You have donated or had more than approximately 450 mL of blood taken in the 30 days before screening
  • For Part 3 only: you have type 1 diabetes, a rare inherited form of diabetes, or any other type of diabetes other than type 2

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Stephen Hall, MBBS, FRACP, Veritus Research

Phone: +91 124 2873900

Australian sites

Veritus Research, Bayswater, Victoria
03 8736 1758 Or 0494 062 402

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Mankind Pharma Limited
Registry
ClinicalTrials.gov
Start date
12 August 2025
Est. completion
19 January 2026

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax); Part 1 - Food effect of single dose of MKP10241 on Apparent total clearance of drug (CL/F); Part 1 - Food effect of single dose of MKP10241 on Time to maximum concentration (Tmax); Part 1 - Food effect of single dose of MKP10241 on elimination half life (t1/2 ); Part 1 - Food effect of single dose of MKP10241 on lag time (Tlag); Part 1 - Food effect of single dose of MKP10241 on Apparent Volume of distribution of drug (V/F); Part 1 - Food effect of single dose of MKP10241 on Area under the curve from time...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov