RecruitingPhase 1ACTRN12624001022550

A Randomised, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MTS-201 in Healthy Volunteers and MTS-201 and Multiple Ascending Doses of MTS-201 in Combination with Sitagliptin in Obese, Otherwise Healthy Volunteers,

Sponsor

METiS Pharmaceuticals Australia Pty Ltd

Enrollment

80 participants

Start Date

Sep 23, 2024

Study Type

Interventional

Conditions

Obesity Type 2 Diabetes Mellitus

Summary

MTS-201 is being developed by METis Pharmaceuticals for the potential treatment of metabolic diseases such as obesity and type 2 diabetes mellitus. This is a randomised, double-blind, placebo-controlled study conducted in healthy adult volunteers. The study will be conducted in 3 parts: Part A: Single Ascending dose of MTS-201 or placebo Part B: Multiple Ascending dose MTS-201 or placebo Part C: MTS-201 in combination with sitagliptin or placebo (Combination) Decisions about how and when to move between cohorts will be based on reviews of the available blinded safety data and available pharmacokinetic (PK) data: this data will be reviewed by a prespecified Safety Review Committee (SRC).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

MTS-201 is a new medication being developed to treat metabolic conditions like obesity and type 2 diabetes. This is a Phase 1 'first in human' safety and pharmacology study — meaning its main purpose is to establish whether the drug is safe and how it behaves in the body, not yet to prove it works. The study has three parts: testing single increasing doses in healthy volunteers (Part A), testing multiple doses in overweight volunteers (Part B), and testing MTS-201 combined with sitagliptin (a diabetes medication) in overweight volunteers (Part C). Participants will receive either the active drug or a placebo in a blinded fashion (neither they nor the researchers know who is getting which), and will be carefully monitored for safety and side effects. Blood samples will track how the drug is processed by the body. For Part A, healthy adults aged 18 to 65 with a BMI of 18 to 32 may be eligible. For Parts B and C, adults with a BMI of 30 to 40 and no diabetes diagnosis are needed. People with significant health conditions, history of obesity surgery, recent major illness, drug or alcohol abuse, or prior use of GLP-1 medications or diabetes treatments are not eligible. Many detailed criteria apply. The study is run by METiS Pharmaceuticals Australia.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study involves evaluation of MTS-201 in Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and in Combination with sitagliptin. Part A (SAD): Participants will receive a single dose of

The study involves evaluation of MTS-201 in Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and in Combination with sitagliptin. Part A (SAD): Participants will receive a single dose of MTS-201 or placebo oral capsules on Day 1 at up to 4 dose regimens: • Cohort 1: 50 mg • Cohort 2: 150 mg • Cohort 3: 450 mg • Cohort 4: 900 mg The decision to escalate between dose levels in Part A will be based upon review of blinded available safety, tolerability and pharmacokinetic (PK) data, up to and including Day 4 from the current cohort, by a Safety Review Committee (SRC). Part B (MAD): Participants will receive twice daily dose of MTS-201 or placebo/placebo oral capsules from Days 1-28 at up to 3 dose regimens: Cohort 1: 150 mg (300 mg/day on Days 1 to 28) + sitagliptin 100 mg once daily (Days 22 to 28 only) • Cohort 2: 300 mg (600 mg/day on Days 1 to 28) + sitagliptin 100 mg once daily (Days 22 to 28 only) • Cohort 3: 450 mg (900 mg/day on Days 1 to 28) + sitagliptin 100 mg once daily (Days 22 to 28 only) The decision to proceed from Part A to Part B will be based upon review of blinded available safety for Part A cohorts by an SRC. Part C (Combination): Participants will receive twice daily dose of 450mg MTS-201 oral capsules + Sitagliptin 100mg (once daily) or placebo/placebo for days 1-28. The decision to proceed to Part C will be based upon review of blinded available safety of Part B cohorts by an SRC. Study drug will be administered to the participants by the site staff while admitted at the clinical site. Adherence to the intervention will be done via supervised drug administration.