Overweight , ObesityPhase 2NCT07791537
Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight
A Phase 2 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 study is a multicenter, randomized, double-blind, placebo-controlled phase II study conducted in China. It aims to evaluate the efficacy and safety of MWN109 injection in non-diabetic overweight or obese participants. A total of 125 participants were enrolled in the study. 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
- 125 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to Nov 2026
- Phase
- Phase 2
- 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 individuals aged 18 to 65 years (inclusive), as determined by the date of signing the informed consent form;
- Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI < 30 kg/m² (overweight) and at least one weight-related comorbidity (such as hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular diseases, polycystic ovary syndrome, etc.);
- Resting heart rate ≥ 55 and ≤ 90 beats per minute (based on 12-lead electrocardiogram results during screening and before randomization);
- Self-reported or documented weight control through diet and exercise for at least 12 weeks, with a weight change of less than 5.0% within the 12 weeks prior to screening;
- No pregnancy plans from the date of signing the informed consent until 4 months after the last dose of the investigational drug; must voluntarily use effective contraception and have no plans for sperm or egg donation.
Who cannot join
- It is known that the subject has an allergic constitution, or is allergic to any component of glucagon-like peptide-1 (GLP-1) receptor agonist drugs or investigational medicinal products, or has a severe allergic disease during screening, or has a history of severe drug allergy in the past;
- 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;
- It is known or discovered during screening that the electrocardiogram is abnormal and there is a significant safety risk, or further diagnosis and treatment are required, including but not limited to: arrhythmias that cannot be controlled or require drug treatment such as persistent ventricular tachycardia, second or third degree atrioventricular block, QTcF > 450 ms, long QT syndrome family history or Brugada syndrome family history, etc.
- There is a history or evidence of any of the following diseases: secondary or drug-induced overweight or obesity; previous diagnosis of type 1 or type 2 diabetes, or at least one laboratory test indicator suggesting diabetes during screening; previous diagnosis of acute or chronic pancreatitis, or pancreatic injury; history of gallstones or cholecystitis during screening; previous diagnosis of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia type 2A or 2B, or a related family history; previously undergone gastric weight loss surgery or other weight loss surgeries, or plans to undergo weight loss surgery, liposuction, abdominal lipolysis, or other surgeries that significantly affect body weight during the study period; previously had moderate or severe depression; diagnosed with a malignant tumor within the previous 5 years or evaluated as having potential malignant tumors during screening; history of any heart disease within 6 months before screening or before randomization; cerebrovascular accident within 6 months before screening or before randomization; uncontrolled hypertension during the screening period; history of hyperthyroidism or hypothyroidism, or clinically significant abnormal thyroid function test results during screening; clinically significant gastric emptying abnormalities, requires long-term use of drugs that directly affect gastrointestinal motility, or active gastrointestinal diseases during screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial Assessing the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
This study is a multicenter, randomized, double-blind, placebo-controlled phase II study conducted in China. It aims to evaluate the efficacy and safety of MWN109 injection in non-diabetic overweight or obese participants.
A total of 125 participants were enrolled in the study. All participants were randomly assigned using stratified block randomization by gender (male or female) and allocated to 4 treatment groups at a 1:1:1:1 ratio, with approximately 30 participants in each group. Each treatment group will reach the target dose through dose titration.
This study consists of a screening period of up to 2 weeks, a treatment period of 36 weeks, and a follow-up period of 4 weeks, totaling 42 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 36 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 36 weeks of treatment, as well as the change in waist circumference relative to the baseline.
- 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, 36 weeks
MWN109 2Drug
Administered SC, QW, 36 weeks
MWN109 3Drug
Administered SC, QW, 36 weeks
PlaceboDrug
Administered SC, QW, 36 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 in body weight compared to baseline after 36 weeks of drug administration
Percentage change in body weight from baseline to Week 36.
Measured: Baseline, Week 36
Secondary outcomes (15)
Change from baseline in body weight over time
Change in body weight from baseline to week 36.
Measured: Baseline, Week 36
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 36
Proportion of participants with a body weight reduction of 5% or more from baseline at Week 36.
Measured: Baseline, Week 36
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 36
Proportion of participants with a body weight reduction of 10% or more from baseline at Week 36.
Measured: Baseline, Week 36
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 36
Proportion of participants with a body weight reduction of 15% or more from baseline at Week 36.
Measured: Baseline, Week 36
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 36
Proportion of participants with a body weight reduction of 20% or more from baseline at Week 36.
Measured: Baseline, Week 36
Change from baseline in waist circumference over time
Change in waist circumference from baseline to week 36.
Measured: up to 36 weeks
Change from baseline in body mass index (BMI) over time
Change in BMI from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in lipid profile over time
Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in blood pressure over time
Change in systolic and diastolic blood pressure from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in fasting insulin over time
Change in fasting serum insulin levels from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in fasting plasma glucose (FPG) over time
Change in fasting plasma glucose levels from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Change in HbA1c levels from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in serum uric acid over time
Change in serum uric acid levels from baseline throughout the study.
Measured: up to 36 weeks
Change from baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) score over time
Change in IWQOL-Lite-CT score from baseline throughout the study. The IWQOL-Lite-CT, a 20-item patient-reported outcome (PRO) tool, evaluates weight-related physical and psychosocial function. Each of its 5 response choices (A-E) yields a score from 1 to 5. Total scores range from 20 to 100. Higher composite and total scores are associated with better participant-reported functioning.
Measured: up to 36 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Measured: up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start26 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
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
- NCT07791537
- Sponsor's protocol ID
- MWN109-Ⅱ-WL-2
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 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 2 Trial Assessing the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07791537
- Acronym / sponsor ID
- MWN109-Ⅱ-WL-2
- Conditions
- Overweight , Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 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 study is a multicenter, randomized, double-blind, placebo-controlled phase II study conducted in China. It aims to evaluate the efficacy and safety of MWN109 injection in non-diabetic overweight or obese participants.
A total of 125 participants were enrolled in the study. All participants were randomly assigned using stratified block randomization by gender (male or female) and allocated to 4 treatment groups at a 1:1:1:1 ratio, with approximately 30 participants in each group. Each treatment group will reach the target dose through dose titration.
This study consists of a screening period of up to 2 weeks, a treatment period of 36 weeks, and a follow-up period of 4 weeks, totaling 42 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 36 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 36 weeks of treatment, as well as the change in waist circumference relative to the baseline.
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 individuals aged 18 to 65 years (inclusive), as determined by the date of signing the informed consent form;
- Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI < 30 kg/m² (overweight) and at least one weight-related comorbidity (such as hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular diseases, polycystic ovary syndrome, etc.);
- Resting heart rate ≥ 55 and ≤ 90 beats per minute (based on 12-lead electrocardiogram results during screening and before randomization);
- Self-reported or documented weight control through diet and exercise for at least 12 weeks, with a weight change of less than 5.0% within the 12 weeks prior to screening;
- No pregnancy plans from the date of signing the informed consent until 4 months after the last dose of the investigational drug; must voluntarily use effective contraception and have no plans for sperm or egg donation.
Key exclusion criteria (5 listed)
- It is known that the subject has an allergic constitution, or is allergic to any component of glucagon-like peptide-1 (GLP-1) receptor agonist drugs or investigational medicinal products, or has a severe allergic disease during screening, or has a history of severe drug allergy in the past;
- 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;
- It is known or discovered during screening that the electrocardiogram is abnormal and there is a significant safety risk, or further diagnosis and treatment are required, including but not limited to: arrhythmias that cannot be controlled or require drug treatment such as persistent ventricular tachycardia, second or third degree atrioventricular block, QTcF > 450 ms, long QT syndrome family history or Brugada syndrome family history, etc.
- There is a history or evidence of any of the following diseases: secondary or drug-induced overweight or obesity; previous diagnosis of type 1 or type 2 diabetes, or at least one laboratory test indicator suggesting diabetes during screening; previous diagnosis of acute or chronic pancreatitis, or pancreatic injury; history of gallstones or cholecystitis during screening; previous diagnosis of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia type 2A or 2B, or a related family history; previously undergone gastric weight loss surgery or other weight loss surgeries, or plans to undergo weight loss surgery, liposuction, abdominal lipolysis, or other surgeries that significantly affect body weight during the study period; previously had moderate or severe depression; diagnosed with a malignant tumor within the previous 5 years or evaluated as having potential malignant tumors during screening; history of any heart disease within 6 months before screening or before randomization; cerebrovascular accident within 6 months before screening or before randomization; uncontrolled hypertension during the screening period; history of hyperthyroidism or hypothyroidism, or clinically significant abnormal thyroid function test results during screening; clinically significant gastric emptying abnormalities, requires long-term use of drugs that directly affect gastrointestinal motility, or active gastrointestinal diseases during screening.
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, 36 weeks | Drug | MWN109 Cohort 1 |
| MWN109 2Administered SC, QW, 36 weeks | Drug | MWN109 Cohort 2 |
| MWN109 3Administered SC, QW, 36 weeks | Drug | MWN109 Cohort 3 |
| PlaceboAdministered SC, QW, 36 weeks | Drug | Placebo |
Primary outcome
Percentage change in body weight compared to baseline after 36 weeks of drug administration
Time frame: Baseline, Week 36
Percentage change in body weight from baseline to Week 36.
15 secondary outcomes
Change from baseline in body weight over time
Time frame: Baseline, Week 36
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 36
Time frame: Baseline, Week 36
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 36
Time frame: Baseline, Week 36
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 36
Time frame: Baseline, Week 36
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 36
Time frame: Baseline, Week 36
Change from baseline in waist circumference over time
Time frame: up to 36 weeks
Change from baseline in body mass index (BMI) over time
Time frame: up to 36 weeks
Change from baseline in lipid profile over time
Time frame: up to 36 weeks
Change from baseline in blood pressure over time
Time frame: up to 36 weeks
Change from baseline in fasting insulin over time
Time frame: up to 36 weeks
Change from baseline in fasting plasma glucose (FPG) over time
Time frame: up to 36 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Time frame: up to 36 weeks
Change from baseline in serum uric acid over time
Time frame: up to 36 weeks
Change from baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) score over time
Time frame: up to 36 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to 36 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 28 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 5 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: under way, not looking for participants, as of the sponsor's last update on 28 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight compared to baseline after 36 weeks of drug administration (time frame: Baseline, Week 36). 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 28 Aug 2026.