RecruitingPhase 1ACTRN12625000057482

A phase 1 study to evaluate MWN109 injection in healthy subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Injection in Healthy subjects

Sponsor

Shanghai Minwei Biotechnology Co., Ltd.

Enrollment

72 participants

Start Date

Mar 17, 2025

Study Type

Interventional

Conditions

Obesity Type 2 Diabetes Mellitus

Summary

This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109. A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD). The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study. MWN109 is believed to be a novel recombinant fatty acid chain-modified peptide with GLP-1/GIP/GCG biological activity and a good safety profile. This proposed Phase 1 study of MWN109 will provide preliminary evidence of safety, tolerability, PK, and PD in a healthy volunteer population. These preliminary results will pave the way to quickly enter into Phase 2 proof of concept studies, where it is intended to treat patients with Type 2 Diabetes Mellitus, overweight or obese

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Type 2 diabetes and obesity are two of the most pressing health challenges of our time, affecting hundreds of millions of people worldwide. Current treatments like GLP-1 receptor agonists have shown real promise for blood sugar control and weight loss, and researchers are exploring new molecules that activate multiple hormone pathways simultaneously to achieve even greater effects with fewer side effects. MWN109 is a novel investigational drug that activates three metabolic hormone pathways (GLP-1, GIP, and glucagon) — making it a potential treatment for both type 2 diabetes and obesity. This Phase 1 study is the first time MWN109 will be given to humans. Healthy volunteers will receive either MWN109 or a placebo to assess safety, tolerability, and how the drug behaves in the body at different doses. The results will determine whether it is safe to progress to larger trials in people with diabetes or obesity. You may be eligible if you are a healthy adult aged 18 to 50 years with no significant medical history. For the multiple-dose part of the study, participants need a BMI between 27 and 45 kg/m² with a stable weight. People with a history of diabetes, heart disease, pancreatitis, thyroid tumours, severe psychiatric illness, or significant alcohol or drug use would not be eligible.

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 will consist of 2 parts: SAD part and MAD part. 1. Part A: SAD study in healthy participants- The SAD study is planned to enroll approximately 40 male or female participants who will be a

The study will consist of 2 parts: SAD part and MAD part. 1. Part A: SAD study in healthy participants- The SAD study is planned to enroll approximately 40 male or female participants who will be assigned into 5 sequential dosing cohorts. Each cohort will enroll 8 participants who will be randomized to receive MWN109 injection or placebo in a ratio of 3:1 (6 on MWN109 injection and 2 on placebo). Cohort A1 to A5 will receive the IP doses 0.25, 0.75, 1.5, 3.0, or 6.0 mg. On D1, after at least 10 hours (h) overnight fasting, participants will be dosed with MWN109 or placebo, via SC injection on the abdomen by a qualified member of study staff. 2. Part B: MAD study in healthy participants- In the MAD study, 4 planned dose cohorts (Cohorts B1, B2, B3, and B4) are designed. Approximately 32 male or female participants will be enrolled, with 8 participants per cohort who will be randomized to receive MWN109 injection or placebo in a ratio of 3:1. The IP will be administered via SC injection once weekly (QW) for approximately 4 doses. Cohort B1 to B4 will receive following dose once weekly from week 1 to week 4- B1- 1.5 mg/1.5 mg/1.5 mg/1.5 mg; B2-1.5 mg/3.0 mg/3.0 mg/3.0 mg; B3- 1.5 mg/3.0 mg/4.5 mg/6.0 mg; B4- 1.5 mg/3.0 mg/6.0 mg/9.0 mg. Adherence to the intervention will be from direct observation with timing of meal consumption recorded by the clinical staff.