Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (2)

Percentage Change from Baseline in Body Weight at Week 52
Percentage change in body weight from baseline to Week 52.
Baseline, Week 52
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 52
Proportion of participants with a body weight reduction of 5% or more from baseline at Week 52.
Baseline, Week 52

Secondary Outcomes (14)

Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 52
Baseline, Week 52
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 52
Baseline, Week 52
Change in Waist Circumference from Baseline at Week 52
Baseline, Week 52
Change from Baseline in Waist-to-Height Ratio (WHtR)
up to 52 weeks
Change from Baseline in Body Mass Index (BMI)
up to 52 weeks
+9 more secondary outcomes

Study Arms (4)

MWN109 Cohort 1

EXPERIMENTAL

Drug: MWN109 1

MWN109 Cohort 2

EXPERIMENTAL

Drug: MWN109 2

MWN109 Cohort 3

EXPERIMENTAL

Drug: MWN109 3

Placebo

PLACEBO COMPARATOR

Interventions

MWN109 1Drug

Administered SC, QW, 52 weeks

MWN109 Cohort 1

MWN109 2Drug

Administered SC, QW, 52 weeks

MWN109 Cohort 2

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female aged 18 to 65 years (inclusive) at the time of signing the informed consent form;
Body weight ≥ 70 kg (males) or ≥ 60 kg (females), with BMI ≥ 28 kg/m² (obesity), or 24 kg/m² ≤ BMI \< 28 kg/m² (overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, polycystic ovary syndrome);

Sponsors & Collaborators

Shanghai Minwei Biotechnology Co., Ltd
Industrylead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Linong Ji, Doctor of MeicineCONTACT13910978815 jiln@bjmu.edu.cn

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wanxiang Chen

CONTACT

13359015677 chenwanxiang@minweibiotech.com

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 21, 2026

Study Start

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 2027

You may not qualify if:

Known allergic constitution (allergy to 3 or more foods or drugs), or allergy to GLP-1 receptor agonists or any component of the investigational product, or severe allergic diseases at screening, or history of severe drug allergy.
Use of any anti-hyperglycemic agents, weight-affecting medications, or prescription weight-loss medications for weight control within 12 weeks prior to screening; over-the-counter weight-loss medications or appetite suppressants within 4 weeks.
Laboratory abnormalities: ALT or AST ≥ 3×ULN; total bilirubin ≥ 1.5×ULN; eGFR \< 60 mL/min/1.73m²; hemoglobin \< 110 g/L (males) or \< 100 g/L (females); serum calcitonin ≥ 35 ng/L; TSH \> 6.0 or \< 0.4 mIU/L; fasting triglycerides ≥ 5.64 mmol/L; serum amylase or lipase \> 2.0×ULN.
Known or screening-detected ECG abnormalities with significant safety risk, including: uncontrolled arrhythmias, second-degree or third-degree AV block, ST-T changes suggesting myocardial ischemia, QTcF \> 450 ms, family history of long QT or Brugada syndrome.
Has a medical history or evidence of any of the following conditions: secondary or drug-induced overweight or obesity; diagnosis of type 1 or type 2 diabetes mellitus in the past or at screening, or at least one laboratory finding suggestive of diabetes identified at screening: HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol/L, random plasma glucose ≥ 11.1 mmol/L, or 2-hour plasma glucose during the oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L; acute or chronic pancreatitis; gallstones/cholecystitis (with exceptions); thyroid C-cell carcinoma or MEN 2A/2B; prior bariatric surgery (with exceptions); moderate or severe depression (PHQ-9 ≥ 15), other severe psychiatric disorders, or suicidal risk; malignancy within 5 years (with exceptions); cardiac disease within 6 months; premature beats or tachycardia; cerebrovascular event within 6 months; uncontrolled hypertension; thyroid dysfunction; gastric emptying abnormalities; organ transplant history; autoimmune disease; previous or planned weight-loss treatment.
Pregnant or breastfeeding women.
Previous treatment with MWN109 injection.

Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (14)

Study Arms (4)

MWN109 Cohort 1

MWN109 Cohort 2

MWN109 Cohort 3

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (14)

Study Arms (4)

MWN109 Cohort 1

MWN109 Cohort 2

MWN109 Cohort 3

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations