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Tests treatment safety and results for Type 2 Diabetes Mellitus (T2DM)
Official title Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
ClinicalTrials.gov ID: NCT07098663
What this study is testing
What is MKP10241?
MKP10241 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type 2 diabetes mellitus (t2dm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join 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...
- 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.
You likely can't join 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...
- Renal impairment, such as creatinine ≥ULN, estimated glomerular filtration rate (eGFR) of ≤80 mL/minute/1.73m2 in adults, as calculated by the...
- 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,
See the full eligibility criteria
- 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...
- 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...
- 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
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bayswater, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayswater, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.