Overweight , ObesityPhase 2NCT07804797
Phase 2 Study of MWN109 Tablet for Weight-Loss Maintenance in Participants With Overweight or Obesity
A Phase 2 study testing MWN109 1 and MWN109 2 in people with Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial summary
This study adopted a randomized, open-label design, aiming to preliminarily explore the weight-loss maintenance effect of MWN109 tablets when administered continuously for 24 weeks in non-diabetic overweight or obese participants. 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 and MWN109 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to Sep 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
- Participate in the multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial (MWN109-II-WL) to evaluate the efficacy and safety of MWN109 injection in adult non-diabetic overweight or obese participants in China; complete the EOT visit and safety follow-up of the participants.
- Participants whose weight decreased by ≥5% compared to baseline at the EOT visit of the MWN109-II-WL study.
- Participants with a BMI > 18.5 kg/m² at the time of the safety follow-up in the MWN109-II-WL study and at the time of randomization at Visit 2 (V2) of this study, and who were evaluated by the investigator as suitable for participating in this study.
- Agree not to use other weight-loss drugs or treatments during the study period.
- From the time of signing the informed consent until 3 months after the last dose of the investigational drug, the participant must have no intention of becoming pregnant and must voluntarily use effective contraceptive measures to prevent pregnancy (or ensure their partner does). There must be no plans for sperm or egg donation. Participants of childbearing potential must not be breastfeeding, and the pregnancy test result prior to randomization must be negative.
Who cannot join
- Previously diagnosed with type 1, type 2, or any other type of diabetes (excluding gestational diabetes).
- At the EOT visit of the MWN109-II-WL study, the fasting plasma glucose in the central laboratory was ≥ 7.0 mmol/L, or the HbA1c was ≥ 6.5%.
- At the screening stage, the PHQ-9 questionnaire score was ≥ 15; or at the screening stage, there was a suicidal tendency or suicidal behavior, or the subject was judged to have a suicidal risk.
- Plans to participate in another clinical study of a trial drug or device before completing all the scheduled assessments in this clinical study, or to take drugs or non-drug treatments that affect weight (excluding diet and exercise control).
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
About this study
Official title: A Multicenter, Randomized, Open-label, Phase 2 Extension Clinical Study Evaluating the Efficacy and Safety of MWN109 Tablets in Weight Loss Maintenance in Non-Diabetic Participants With Overweight or Obesity
This study adopted a randomized, open-label design, aiming to preliminarily explore the weight-loss maintenance effect of MWN109 tablets when administered continuously for 24 weeks in non-diabetic overweight or obese participants.
Participants who met the inclusion criteria were randomly assigned (1:1) to either the QD or QW administration group of MWN109 tablets, with the dose grouping in the MWN109-II-WL study serving as a random stratification factor.
This study included a maximum screening period of 2 weeks, a 24-week treatment observation period, and a 2-week safety follow-up period, totaling 28 weeks. The primary endpoint was the percentage change in weight from baseline after 24 weeks of administration. The secondary endpoints included the change in weight from baseline after 24 weeks of administration, as well as the change in waist circumference from baseline.
- Conditions
- Overweight , Obesity
- Being tested
- MWN109 1, MWN109 2
- 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, 24 weeks
MWN109 2Drug
Administered orally, QW, 24 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 |
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 24 weeks of drug administration
Percentage change in body weight from baseline to Week 24.
Measured: Baseline, Week 24
Secondary outcomes (8)
Change from baseline in body weight over time
Change in body weight from baseline to week 24.
Measured: Baseline, Week 24
The proportion of participants whose weight remained unchanged from baseline to week 24
Proportion of participants with body weight unchanged from baseline at week 24.
Measured: Baseline, Week 24
Change from baseline in waist circumference over time
Change in waist circumference from baseline to week 24.
Measured: up to 24 weeks
Change from baseline in body mass index (BMI) over time
Change in BMI from baseline throughout the study.
Measured: up to 24 weeks
Change from baseline in waist-to-hip ratio (WHR) over time
Change in WHR from baseline throughout the study.
Measured: up to 24 weeks
Time to first body weight greater than baseline at two consecutive visits
Time to the first occurrence of body weight greater than the baseline level at two consecutive visits (calculated based on the time of the second visit).
Measured: up to 24 weeks
Change from Baseline in IWQOL-Lite-CT Score over time
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 indicate better functional status of the participants.
Measured: up to 24 weeks
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 start2 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 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.
- 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
- None (open label)
- Enrolment
- 71 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
- NCT07804797
- Sponsor's protocol ID
- MWN109-Oral-II-MTN
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 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, Open-label, Phase 2 Extension Clinical Study Evaluating the Efficacy and Safety of MWN109 Tablets in Weight Loss Maintenance in Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07804797
- Acronym / sponsor ID
- MWN109-Oral-II-MTN
- Conditions
- Overweight , Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- 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 study adopted a randomized, open-label design, aiming to preliminarily explore the weight-loss maintenance effect of MWN109 tablets when administered continuously for 24 weeks in non-diabetic overweight or obese participants.
Participants who met the inclusion criteria were randomly assigned (1:1) to either the QD or QW administration group of MWN109 tablets, with the dose grouping in the MWN109-II-WL study serving as a random stratification factor.
This study included a maximum screening period of 2 weeks, a 24-week treatment observation period, and a 2-week safety follow-up period, totaling 28 weeks. The primary endpoint was the percentage change in weight from baseline after 24 weeks of administration. The secondary endpoints included the change in weight from baseline after 24 weeks of administration, as well as the change in waist circumference from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWN109 Cohort 1 | Experimental | Drug: MWN109 1 |
| MWN109 Cohort 2 | Experimental | Drug: MWN109 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participate in the multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial (MWN109-II-WL) to evaluate the efficacy and safety of MWN109 injection in adult non-diabetic overweight or obese participants in China; complete the EOT visit and safety follow-up of the participants.
- Participants whose weight decreased by ≥5% compared to baseline at the EOT visit of the MWN109-II-WL study.
- Participants with a BMI > 18.5 kg/m² at the time of the safety follow-up in the MWN109-II-WL study and at the time of randomization at Visit 2 (V2) of this study, and who were evaluated by the investigator as suitable for participating in this study.
- Agree not to use other weight-loss drugs or treatments during the study period.
- From the time of signing the informed consent until 3 months after the last dose of the investigational drug, the participant must have no intention of becoming pregnant and must voluntarily use effective contraceptive measures to prevent pregnancy (or ensure their partner does). There must be no plans for sperm or egg donation. Participants of childbearing potential must not be breastfeeding, and the pregnancy test result prior to randomization must be negative.
Key exclusion criteria (4 listed)
- Previously diagnosed with type 1, type 2, or any other type of diabetes (excluding gestational diabetes).
- At the EOT visit of the MWN109-II-WL study, the fasting plasma glucose in the central laboratory was ≥ 7.0 mmol/L, or the HbA1c was ≥ 6.5%.
- At the screening stage, the PHQ-9 questionnaire score was ≥ 15; or at the screening stage, there was a suicidal tendency or suicidal behavior, or the subject was judged to have a suicidal risk.
- Plans to participate in another clinical study of a trial drug or device before completing all the scheduled assessments in this clinical study, or to take drugs or non-drug treatments that affect weight (excluding diet and exercise control).
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, 24 weeks | Drug | MWN109 Cohort 1 |
| MWN109 2Administered orally, QW, 24 weeks | Drug | MWN109 Cohort 2 |
Primary outcome
Percentage change in body weight compared to baseline after 24 weeks of drug administration
Time frame: Baseline, Week 24
Percentage change in body weight from baseline to Week 24.
8 secondary outcomes
Change from baseline in body weight over time
Time frame: Baseline, Week 24
The proportion of participants whose weight remained unchanged from baseline to week 24
Time frame: Baseline, Week 24
Change from baseline in waist circumference over time
Time frame: up to 24 weeks
Change from baseline in body mass index (BMI) over time
Time frame: up to 24 weeks
Change from baseline in waist-to-hip ratio (WHR) over time
Time frame: up to 24 weeks
Time to first body weight greater than baseline at two consecutive visits
Time frame: up to 24 weeks
Change from Baseline in IWQOL-Lite-CT Score over time
Time frame: up to 24 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: up to 24 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 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 MWN109 1 and MWN109 2 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 4 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 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. 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 24 weeks of drug administration (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.