Clinical trials

This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants. The study consists of two parts. Part A includes two dose cohorts enrolling healthy participants, and Part B includes four dose cohorts enrolling obese participants. A total of 48 participants will be enrolled. Within each dose cohort, participants will be randomly assigned to receive a single subcutaneous injection of MWN117 or matching placebo. The primary endpoint is safety, assessed by adverse events and related examinations. Secondary endpoints include plasma pharmacokinetic (PK) parameters and urine PK parameters.

This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase 1 clinical study, aimed at evaluating the safety, tolerability, PK, PD and immunogenicity of single subcutaneous administration of MWX401 Injection in healthy Chinese participants and participants with primary mild hypertension. The study comprises five dose cohorts with a planned enrollment of 46 subjects. The primary endpoint is the incidence and severity of treatment-emergent adverse events. Secondary endpoints include plasma and urinary PK parameters, changes in serum AGT and RAAS components, changes in blood pressure and hemodynamics, and immunogenicity indicators.

This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants. The study plans to enroll 36 male and female participants. Three dose groups were preset, with 12 participants in each. They were randomly assigned to receive MWN105 injection or placebo at a ratio of 5:1 and were administered the treatment in a titration manner, once a week, with a dose increase every two weeks until reaching the target dose. The administration lasted for 8 weeks. The study consists of a 2-week screening period, an 8-week administration/observation period, and a 4-week follow-up period, totaling 14 weeks. The primary endpoint is the incidence of adverse events. Secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.

This is a multicenter, randomized, blinded, placebo-controlled Phase 2 study designed to preliminarily evaluate the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of MWX203 Injection alone or in combination with Inclisiran Sodium Injection in participants with mixed dyslipidemia who have inadequate lipid control despite stable statin therapy. The study includes 5 parallel arms with a planned enrollment of 216 Chinese participants. The study drug is administered subcutaneously once every 12 weeks for a total of 2 doses. The double-blind treatment period lasts 36 weeks, and participants whose lipid levels do not return to baseline will enter a 12-week extended follow-up period. The primary endpoint is the percentage change in serum triglyceride (TG) level from baseline at Week 24.

This is a randomized, double-blind, placebo- and active-controlled, multicenter Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of MWN109 tablets in participants with type 2 diabetes mellitus (T2DM). Eligible participants will be randomized to receive different dose levels of MWN109 tablets, MWN109-matched placebo, or semaglutide tablets 14 mg (active control), administered once daily for 20 consecutive weeks. Approximately 240 adults aged 18 to 75 years with type 2 diabetes mellitus will be enrolled. The primary endpoint is the percent change from baseline in HbA1c at Week 20. Secondary endpoints include glycemic parameters, body weight, metabolic parameters, adverse events, and immunogenicity.

This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants. The study consists of two parts: Part 1, a single ascending dose (SAD) study in healthy participants with 8 dose cohorts; and Part 2, a multiple ascending dose (MAD) study in overweight or obese participants with 3 dose cohorts, with a dosing frequency of once weekly or once every 4 weeks. Approximately 103 participants will be enrolled. The primary endpoint is safety and tolerability, assessed by adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and ophthalmic examination. Secondary endpoints include single-dose and multiple-dose PK parameters, PD parameters (body weight, BMI, waist circumference, muscle mass, body fat percentage, visceral fat, subcutaneous fat, bone mineral density), and immunogenicity (anti-drug antibodies).

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity. Approximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose. The study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.

This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia). Researchers will check if a single dose of MWX205 is safe and how the body reacts to it. They will also measure how quickly the drug enters the bloodstream and how long it stays in the body, and compare it with a placebo (inactive treatment). The study will help decide the right dose and understand how this medicine could be used in future treatments. The main questions this study aims to answer are: 1. Is MWX205 safe after a single dose? 2. How does the body process MWX205? 3. Does MWX205 show any effect on the body related to cholesterol levels?

This is a Phase 1, randomized, double-blind, placebo-controlled, single-and-multiple ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of orally administered MWN109 tablets will be assessed in healthy adult participants.

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.