Overweight , ObesityPhase 2NCT07791524
Phase 2 Study of MWN109 Tablet in Participants With Overweight or Obesity
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 is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial to preliminarily evaluate the efficacy, safety, and PK of MWN109 tablets administered orally once daily in non-diabetic participants with overweight or obesity. Approximately 240 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 9 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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);
- The subject has undertaken weight management via diet and exercise alone for at least 12 weeks prior to screening, with a weight change of <5.0% (self-reported), and is able to continue the same diet-and-exercise-based weight management during the study period.
- Participants must have no pregnancy plans from the time of signing informed consent until 3 months after the last dose of the investigational product, must use effective contraception to avoid pregnancy or partner pregnancy, and must have no plans to donate sperm or eggs.
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 Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Tablet in Non-Diabetic Participants With Overweight or Obesity
This is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial to preliminarily evaluate the efficacy, safety, and PK of MWN109 tablets administered orally once daily in non-diabetic participants with overweight or obesity.
Approximately 240 participants will be enrolled. All participants will be stratified by gender (male or female) and then randomized 1:1:1:1:1 to 5 treatment groups, with approximately 48 participants per group. All treatment groups will implement dose titration to achieve the target dose.
This study consists of a screening period of up to 2 weeks, a treatment period of 20 weeks, and a follow-up period of 2 weeks, totaling 24 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 20 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 20 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, MWN109 4, 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 orally, QD, 20 weeks
MWN109 2Drug
Administered orally, QD, 20 weeks
MWN109 3Drug
Administered orally, QD, 20 weeks
MWN109 4Drug
Administered orally, QD, 20 weeks
PlaceboDrug
Administered orally, QD, 20 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 |
| MWN109 Cohort 4 | Experimental | Not described Receives: Drug: MWN109 4 |
| 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 20 weeks of drug administration
Percentage change in body weight from baseline to Week 20.
Measured: Baseline, week 20
Secondary outcomes (15)
Change from baseline in body weight over time
Change in body weight from baseline to week 20.
Measured: Baseline, week 20
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 5% or more from baseline at week 20.
Measured: Baseline, week 20
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 10% or more from baseline at week 20.
Measured: Baseline, week 20
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 15% or more from baseline at week 20.
Measured: Baseline, week 20
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at week 20
Proportion of participants with a body weight reduction of 20% or more from baseline at week 20.
Measured: Baseline, week 20
Change from baseline in waist circumference over time
Change in waist circumference from baseline to week 20.
Measured: up to 20 weeks
Change from baseline in body mass index (BMI) over time
Change in BMI from baseline throughout the study.
Measured: up to 20 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 20 weeks
Change from baseline in blood pressure over time
Change in systolic and diastolic blood pressure from baseline throughout the study.
Measured: up to 20 weeks
Change from baseline in fasting insulin over time
Change in fasting serum insulin levels from baseline throughout the study.
Measured: up to 20 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 20 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Change in HbA1c levels from baseline throughout the study.
Measured: up to 20 weeks
Change from baseline in serum uric acid over time
Change in serum uric acid levels from baseline throughout the study.
Measured: up to 20 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 20 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Measured: up to 20 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 start5 Jan 2026
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 255 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
- NCT07791524
- Sponsor's protocol ID
- MWN109-Oral-II
- 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 Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Tablet in Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07791524
- Acronym / sponsor ID
- MWN109-Oral-II
- Conditions
- Overweight , Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- 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 is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial to preliminarily evaluate the efficacy, safety, and PK of MWN109 tablets administered orally once daily in non-diabetic participants with overweight or obesity.
Approximately 240 participants will be enrolled. All participants will be stratified by gender (male or female) and then randomized 1:1:1:1:1 to 5 treatment groups, with approximately 48 participants per group. All treatment groups will implement dose titration to achieve the target dose.
This study consists of a screening period of up to 2 weeks, a treatment period of 20 weeks, and a follow-up period of 2 weeks, totaling 24 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 20 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 20 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
- 5
| Arm | Type | Receives |
|---|---|---|
| MWN109 Cohort 1 | Experimental | Drug: MWN109 1 |
| MWN109 Cohort 2 | Experimental | Drug: MWN109 2 |
| MWN109 Cohort 3 | Experimental | Drug: MWN109 3 |
| MWN109 Cohort 4 | Experimental | Drug: MWN109 4 |
| 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);
- The subject has undertaken weight management via diet and exercise alone for at least 12 weeks prior to screening, with a weight change of <5.0% (self-reported), and is able to continue the same diet-and-exercise-based weight management during the study period.
- Participants must have no pregnancy plans from the time of signing informed consent until 3 months after the last dose of the investigational product, must use effective contraception to avoid pregnancy or partner pregnancy, and must have no plans to donate sperm or eggs.
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 orally, QD, 20 weeks | Drug | MWN109 Cohort 1 |
| MWN109 2Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 2 |
| MWN109 3Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 3 |
| MWN109 4Administered orally, QD, 20 weeks | Drug | MWN109 Cohort 4 |
| PlaceboAdministered orally, QD, 20 weeks | Drug | Placebo |
Primary outcome
Percentage change in body weight compared to baseline after 20 weeks of drug administration
Time frame: Baseline, week 20
Percentage change in body weight from baseline to Week 20.
15 secondary outcomes
Change from baseline in body weight over time
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at week 20
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at week 20
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at week 20
Time frame: Baseline, week 20
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at week 20
Time frame: Baseline, week 20
Change from baseline in waist circumference over time
Time frame: up to 20 weeks
Change from baseline in body mass index (BMI) over time
Time frame: up to 20 weeks
Change from baseline in lipid profile over time
Time frame: up to 20 weeks
Change from baseline in blood pressure over time
Time frame: up to 20 weeks
Change from baseline in fasting insulin over time
Time frame: up to 20 weeks
Change from baseline in fasting plasma glucose (FPG) over time
Time frame: up to 20 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Time frame: up to 20 weeks
Change from baseline in serum uric acid over time
Time frame: up to 20 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 20 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to 20 weeks]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 20 weeks of drug administration (time frame: Baseline, week 20). 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.