Overweight , ObesityPhase 3NCT07778693
Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity
A Phase 3 study testing MWN109 1, MWN109 2 and MWN109 3 in people with Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- MWN109 1, MWN109 2 and MWN109 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 760 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead ECG);
- Self-reported or documented history of dietary and exercise-based weight management for at least 12 weeks prior to screening, with < 5.0% weight change during the 12 weeks prior to screening, and ability to maintain the required diet and exercise behavior during the study;
- Participants of childbearing potential must agree to use highly effective contraception from 14 days before signing the ICF until 4 months after the last dose, with no plans for pregnancy or oocyte donation; male participants must agree to use highly effective contraception from signing the ICF until 4 months after the last dose, with no plans for fathering children or sperm donation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji, Doctor of Meicine, 13910978815, jiln@bjmu.edu.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
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.
- Conditions
- Overweight , Obesity
- Being tested
- MWN109 1, MWN109 2, MWN109 3, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN109 1Drug
Administered SC, QW, 52 weeks
MWN109 2Drug
Administered SC, QW, 52 weeks
MWN109 3Drug
Administered SC, QW, 52 weeks
PlaceboDrug
Administered SC, QW, 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| MWN109 Cohort 1 | Experimental | Not described Receives: Drug: MWN109 1 |
| MWN109 Cohort 2 | Experimental | Not described Receives: Drug: MWN109 2 |
| MWN109 Cohort 3 | Experimental | Not described Receives: Drug: MWN109 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change from Baseline in Body Weight at Week 52
Percentage change in body weight from baseline to Week 52.
Measured: 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.
Measured: Baseline, Week 52
Secondary outcomes (14)
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 52
Proportion of participants with a body weight reduction of 10% or more from baseline at Week 52.
Measured: Baseline, Week 52
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 52
Proportion of participants with a body weight reduction of 15% or more from baseline at Week 52.
Measured: Baseline, Week 52
Change in Waist Circumference from Baseline at Week 52
Change in waist circumference from baseline to week 52.
Measured: Baseline, Week 52
Change from Baseline in Waist-to-Height Ratio (WHtR)
Change in WHtR from baseline throughout the study.
Measured: up to 52 weeks
Change from Baseline in Body Mass Index (BMI)
Change in BMI from baseline throughout the study.
Measured: up to 52 weeks
Change from Baseline in Neck Circumference
Change in neck circumference from baseline throughout the study.
Measured: up to 52 weeks
Change from Baseline in Blood Lipid Parameters
Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study.
Measured: up to 52 weeks
Change from Baseline in Blood Pressure
Change in systolic and diastolic blood pressure from baseline throughout the study.
Measured: up to 52 weeks
Change from Baseline in Glucose Metabolism Parameters
Change in glucose metabolism parameters (including fasting plasma glucose, HbA1c, fasting insulin, HOMA-IR) from baseline throughout the study.]
Measured: up to 52 weeks
Change from Baseline in Serum Uric Acid
Change in serum uric acid from baseline throughout the study.
Measured: up to 52 weeks
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR)
Change in UACR from baseline throughout the study.
Measured: up to 52 weeks
Change in Liver Fat Content (LFC) from Baseline at Week 52
Change in LFC from baseline to week 52.
Measured: up to 52 weeks
Change in IWQOL-Lite-CT Score from Baseline at Week 24 and Week 52
Change in IWQOL-Lite-CT score from baseline to Week 24 and Week 52.
Measured: Baseline, Week 24, Week 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778693
- Sponsor's protocol ID
- MWN109-Ⅲ-WL
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07778693
- Acronym / sponsor ID
- MWN109-Ⅲ-WL
- Conditions
- Overweight , Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MWN109 Cohort 1 | Experimental | Drug: MWN109 1 |
| MWN109 Cohort 2 | Experimental | Drug: MWN109 2 |
| MWN109 Cohort 3 | Experimental | Drug: MWN109 3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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);
- Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead ECG);
- Self-reported or documented history of dietary and exercise-based weight management for at least 12 weeks prior to screening, with < 5.0% weight change during the 12 weeks prior to screening, and ability to maintain the required diet and exercise behavior during the study;
- Participants of childbearing potential must agree to use highly effective contraception from 14 days before signing the ICF until 4 months after the last dose, with no plans for pregnancy or oocyte donation; male participants must agree to use highly effective contraception from signing the ICF until 4 months after the last dose, with no plans for fathering children or sperm donation.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MWN109 1Administered SC, QW, 52 weeks | Drug | MWN109 Cohort 1 |
| MWN109 2Administered SC, QW, 52 weeks | Drug | MWN109 Cohort 2 |
| MWN109 3Administered SC, QW, 52 weeks | Drug | MWN109 Cohort 3 |
| PlaceboAdministered SC, QW, 52 weeks | Drug | Placebo |
Primary outcome
Percentage Change from Baseline in Body Weight at Week 52
Time frame: Baseline, Week 52
Percentage change in body weight from baseline to Week 52.
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 52
Time frame: Baseline, Week 52
Proportion of participants with a body weight reduction of 5% or more from baseline at Week 52.
14 secondary outcomes
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 52
Time frame: Baseline, Week 52
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 52
Time frame: Baseline, Week 52
Change in Waist Circumference from Baseline at Week 52
Time frame: Baseline, Week 52
Change from Baseline in Waist-to-Height Ratio (WHtR)
Time frame: up to 52 weeks
Change from Baseline in Body Mass Index (BMI)
Time frame: up to 52 weeks
Change from Baseline in Neck Circumference
Time frame: up to 52 weeks
Change from Baseline in Blood Lipid Parameters
Time frame: up to 52 weeks
Change from Baseline in Blood Pressure
Time frame: up to 52 weeks
Change from Baseline in Glucose Metabolism Parameters
Time frame: up to 52 weeks
Change from Baseline in Serum Uric Acid
Time frame: up to 52 weeks
Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR)
Time frame: up to 52 weeks
Change in Liver Fat Content (LFC) from Baseline at Week 52
Time frame: up to 52 weeks
Change in IWQOL-Lite-CT Score from Baseline at Week 24 and Week 52
Time frame: Baseline, Week 24, Week 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Related trials for Overweight , Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MWN109 1, MWN109 2 and MWN109 3 in people with Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanxiang Chen (13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change from Baseline in Body Weight at Week 52 (time frame: Baseline, Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.