Overweight , ObesityPhase 2NCT07804810
Phase 2 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity
A Phase 2 study testing MWN105 1, MWN105 2 and MWN105 3 in people with Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity. 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?
- MWN105 1, MWN105 2 and MWN105 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2025to 16 Apr 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 participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF).
- Body weight ≥ 70 kg (male) or ≥ 60 kg (female), with body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI < 30 kg/m² (overweight) accompanied by at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, or polycystic ovary syndrome).
- Self-reported or documented diet and exercise control of body weight for 12 weeks or more, with body weight change of less than 5.0% within 12 weeks prior to screening.
Who cannot join
- Known hypersensitivity to GLP-1 receptor agonists, any component of the investigational product, or history of severe allergic disease or severe drug allergy.
- Use of medications that may affect glucose metabolism or body weight before screening, including antidiabetic drugs, systemic glucocorticoids, psychotropic drugs associated with weight change, prescription weight-loss drugs within 12 weeks, or over-the-counter weight-loss drugs/appetite suppressants within 4 weeks.
- Clinically significant laboratory abnormalities at screening or before randomization, including:
- ALT or AST ≥3 × ULN, or TBIL ≥1.5 × ULN.
- eGFR <60 mL/min/1.73 m².
- Hemoglobin <110 g/L in males or <100 g/L in females.
Show all 27Show fewer
- Calcitonin ≥35 ng/L.
- TSH >6.0 or <0.4 mIU/L.
- Fasting triglycerides ≥5.64 mmol/L.
- Amylase or lipase >2 × ULN.
- History or presence of clinically significant diseases or conditions that may affect body weight, safety, or study assessments, including:
- Secondary or drug-induced overweight/obesity.
- Type 1 or type 2 diabetes mellitus, or laboratory evidence of diabetes (HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or random/2-hour OGTT plasma glucose ≥11.1 mmol/L).
- Acute or chronic pancreatitis or pancreatic injury.
- Gallstones or cholecystitis, except adequately treated cases without residual disease.
- Medullary thyroid carcinoma, MEN 2A/2B, or relevant family history.
- Previous bariatric surgery or planned procedures that may significantly affect body weight.
- Moderate or severe depression, PHQ-9 score ≥15, severe psychiatric disorders, suicidal ideation/behavior, or suicide risk.
- Malignancy within 5 years, except specified adequately treated localized cancers.
- Significant cardiovascular or cerebrovascular disease within 6 months before screening/randomization.
- Osteoporosis defined as T-score ≤-2.5 or Z-score ≤-2.0, as applicable.
- Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg).
- Clinically significant thyroid dysfunction.
- Significant gastric emptying disorders or active gastrointestinal disease.
- History of organ transplantation or awaiting transplantation.
- Autoimmune diseases likely to require systemic glucocorticoids.
- Current participation in an active weight-loss program not yet in the maintenance phase.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Pharmacokinetic Characteristics, Efficacy, and Safety of MWN105 Injection in Non-Diabetic Participants With Overweight or Obesity
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity.
Approximately 120 participants will be randomized to receive different dose levels of MWN105 Injection or matching placebo, administered subcutaneously once weekly for a total treatment duration of 24 weeks, with dose titration from 15 mg to the target dose.
The primary endpoint is the percent change from baseline in body weight at Week 24. Secondary endpoints include changes in body weight and metabolic parameters, bone mineral density, pharmacokinetic parameters, immunogenicity, and safety.
- Conditions
- Overweight , Obesity
- Being tested
- MWN105 1, MWN105 2, MWN105 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.
MWN105 1Drug
Administered SC, QW, 24 weeks
MWN105 2Drug
Administered SC, QW, 24 weeks
MWN105 3Drug
Administered SC, QW, 24 weeks
PlaceboDrug
Administered SC, QW, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| MWN105 Cohort 1 | Experimental | Not described Receives: Drug: MWN105 1 |
| MWN105 Cohort 2 | Experimental | Not described Receives: Drug: MWN105 2 |
| MWN105 Cohort 3 | Experimental | Not described Receives: Drug: MWN105 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 24.
Measured: Baseline, Week 24
Secondary outcomes (14)
Change from baseline in body weight over time
Change in body weight from baseline throughout the study.
Measured: up to 24 weeks
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 24
Measured: Baseline, Week 24
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 24
Measured: Baseline, Week 24
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 24
Measured: Baseline, Week 24
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 24
Measured: Baseline, Week 24
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 24 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 24 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Change in HbA1c levels from baseline throughout the study.
Measured: up to 24 weeks
Change from baseline in adiponectin over time
Change in adiponectin levels from baseline throughout the study.
Measured: up to 24 weeks
Change from baseline in alanine aminotransferase (ALT) over time[
Change in ALT levels from baseline throughout the study.
Measured: up to 24 weeks
Change from baseline in aspartate Aminotransferase (AST) over time
Change in ALT levels from baseline throughout the study.
Measured: up to 24 weeks
Change from baseline in serum uric acid over time
Change in serum uric acid levels from baseline throughout the study.
Measured: up to 24 weeks
Change from Baseline in Liver Fat Content (LFC) at Week 24
Change in LFC from baseline to Week 24.
Measured: Baseline, Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start3 Sep 2025
- Primary completion21 Mar 2026
- Study completion16 Apr 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
- 120 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
- NCT07804810
- Sponsor's protocol ID
- MWN105-II-WL
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 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 4 Sep 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 Clinical Study to Evaluate the Pharmacokinetic Characteristics, Efficacy, and Safety of MWN105 Injection in Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07804810
- Acronym / sponsor ID
- MWN105-II-WL
- Conditions
- Overweight , Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 21 Mar 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 4 Sep 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 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity.
Approximately 120 participants will be randomized to receive different dose levels of MWN105 Injection or matching placebo, administered subcutaneously once weekly for a total treatment duration of 24 weeks, with dose titration from 15 mg to the target dose.
The primary endpoint is the percent change from baseline in body weight at Week 24. Secondary endpoints include changes in body weight and metabolic parameters, bone mineral density, pharmacokinetic parameters, immunogenicity, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MWN105 Cohort 1 | Experimental | Drug: MWN105 1 |
| MWN105 Cohort 2 | Experimental | Drug: MWN105 2 |
| MWN105 Cohort 3 | Experimental | Drug: MWN105 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 (3 listed)
- Male or female participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF).
- Body weight ≥ 70 kg (male) or ≥ 60 kg (female), with body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI < 30 kg/m² (overweight) accompanied by at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, or polycystic ovary syndrome).
- Self-reported or documented diet and exercise control of body weight for 12 weeks or more, with body weight change of less than 5.0% within 12 weeks prior to screening.
Key exclusion criteria (27 listed)
- Known hypersensitivity to GLP-1 receptor agonists, any component of the investigational product, or history of severe allergic disease or severe drug allergy.
- Use of medications that may affect glucose metabolism or body weight before screening, including antidiabetic drugs, systemic glucocorticoids, psychotropic drugs associated with weight change, prescription weight-loss drugs within 12 weeks, or over-the-counter weight-loss drugs/appetite suppressants within 4 weeks.
- Clinically significant laboratory abnormalities at screening or before randomization, including:
- History or presence of clinically significant diseases or conditions that may affect body weight, safety, or study assessments, including:
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 |
|---|---|---|
| MWN105 1Administered SC, QW, 24 weeks | Drug | MWN105 Cohort 1 |
| MWN105 2Administered SC, QW, 24 weeks | Drug | MWN105 Cohort 2 |
| MWN105 3Administered SC, QW, 24 weeks | Drug | MWN105 Cohort 3 |
| PlaceboAdministered SC, QW, 24 weeks | Drug | Placebo |
Primary outcome
Percentage Change from Baseline in Body Weight at Week 24.
Time frame: Baseline, Week 24
14 secondary outcomes
Change from baseline in body weight over time
Time frame: up to 24 weeks
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
Change from baseline in lipid profile over time
Time frame: up to 24 weeks
Change from baseline in fasting plasma glucose (FPG) over time
Time frame: up to 24 weeks
Change from baseline in glycated hemoglobin (HbA1c) over time
Time frame: up to 24 weeks
Change from baseline in adiponectin over time
Time frame: up to 24 weeks
Change from baseline in alanine aminotransferase (ALT) over time[
Time frame: up to 24 weeks
Change from baseline in aspartate Aminotransferase (AST) over time
Time frame: up to 24 weeks
Change from baseline in serum uric acid over time
Time frame: up to 24 weeks
Change from Baseline in Liver Fat Content (LFC) at Week 24
Time frame: Baseline, Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to 24 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 4 Sep 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 MWN105 1, MWN105 2 and MWN105 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 3 inclusion and 27 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 4 Sep 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 from Baseline in Body Weight at Week 24. (time frame: Baseline, Week 24). 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 4 Sep 2026.