Overweight , ObesityPhase 1NCT07787728
Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity
A Phase 1 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 randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese 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?
- MWN109 1, MWN109 2 and MWN109 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2025to 16 Dec 2025
- Phase
- Phase 1
- 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 between 18 and 65 years old (inclusive of 18 and 65 years old), as determined by the date of signing the informed consent form.
- Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a BMI ranging from 27.0 to 35.0 kg/m2.
- Resting heart rate ≥ 55 beats per minute and ≤ 90 beats per minute (results of 12-lead electrocardiogram before randomization).
- Self-reported or documented weight change before the screening period of 12 weeks was less than 5.0%, and the participant can maintain their original diet and lifestyle during the trial period.
- Participants must have no pregnancy plans from the time of signing the informed consent form until 4 months after the last dose of the investigational drug.
Who cannot join
- Individuals with a known allergy to GLP - 1 receptor agonist drugs or the excipient components of MWN109 injection, or those with severe allergic diseases or a severe allergic constitution at the time of screening.
- Used GLP-1 receptor agonists or similar drugs targeting the same site, drugs that affect body weight, or weight-loss drugs within 12 weeks before screening.
- Laboratory abnormalities: HbA1c ≥ 6.5%, or fasting blood glucose ≥ 7.0 mmol/L, or 2-hour blood glucose in the OGTT≥ 11.1 mmol/L (participants with fasting blood glucose between 6.1 and 6.9 mmol/L at the time of screening need to undergo the OGTT), ALT or AST ≥ 2.5ULN, or total serum bilirubin ≥ 1.5ULN. Serum amylase or serum lipase ≥ 1.5ULN. eGFR< 60 mL/min/1.73 m². Serum calcitonin level ≥ 35 ng/L (pg/mL). TSH> 6.0 mIU/L or < 0.4 mIU/L. Triglycerides ≥ 5.64 mmol/L (500 mg/dL). HGB< 110 g/L (for males) or < 100 g/L (for females).
- ECG shows second- or third-degree atrioventricular block, long QT syndrome (QTcF > 470 ms for females or > 450 ms for males), pre-excitation syndrome, or other ECG abnormalities that the investigator deems require drug intervention.
- Participants with a history or evidence of any of the following diseases:
- Obesity secondary to other diseases or drug use.
Show all 19Show fewer
- Previously or currently diagnosed with type 1 or type 2 diabetes at the time of screening.
- Previously or currently diagnosed with acute or chronic pancreatitis, or pancreatic injury at the time of screening;.
- Previous diagnosis of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia type 2A or 2B, or with a relevant family history.
- Previously undergone gastric weight-loss surgery, or planning to undergo weight-loss surgery, liposuction, or abdominal fat-reduction surgery during the study, which can significantly affect body weight.
- A history of past or current depression, other severe mental illnesses, or a history of suicidal tendencies or behaviors.
- Diagnosed with a malignant tumor within 5 years before screening (except for cured carcinoma in situ), or with a potential malignant tumor as evaluated at the time of screening.
- A history of any of the following heart diseases within 6 months before screening.
- Suffered from hemorrhagic or ischemic stroke within 6 months before screening and deemed ineligible to participate in this clinical trial by the investigator.
- Experienced severe hypoglycemia or recurrent (≥ 2 times within 6 months) symptomatic hypoglycemia within 6 months before screening.
- Participants with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at the time of screening) after treatment, or those with untreated blood pressure reaching the above-mentioned criteria at the time of screening.
- Abnormal thyroid function that cannot be controlled with a stable drug dosage at the time of screening, or abnormal thyroid function test results with clinical significance that require initiation of treatment at the time of screening.
- Abdominal ultrasound at the time of screening indicates symptomatic gallbladder polyps or other gallbladder diseases that require treatment, or gallbladder diseases with symptoms that the investigator deems require treatment.
- Clinically significant gastric emptying abnormalities, gastric reflux disease, active gastrointestinal diseases, etc., present at the time of screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Subcutaneous Administrations of MWN109 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity
This study is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese non-diabetic participants with overweight or obesity.
A total of 40 participants were enrolled in the study. All participants were stratified and randomized by gender, and randomly assigned to 4 dose groups at a ratio of 1:1:1:1, with 10 participants in each group(8 participants received MWN109 injection, and 2 received placebo). Each treatment group will use a dose titration method to reach the target dose.
The study includes a maximum screening period of up to 2 weeks, a 14-week treatment period and a 2-week follow-up period, totaling 18 weeks. The primary endpoint is the incidence of adverse events. The secondary endpoint is the pharmacokinetic characteristics.
- 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 SC, QW, 14 weeks
MWN109 2Drug
Administered SC, QW, 14 weeks
MWN109 3Drug
Administered SC, QW, 14 weeks
MWN109 4Drug
Administered SC, QW, 14 weeks
PlaceboDrug
Administered SC, QW, 14 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.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability assessed by the incidence of AEs and SAEs.
Measured: From Day 1 to Day 113
Secondary outcomes (12)
Maximum Concentration (Cmax)
Cmax of MWN109.
Measured: From Day 1 to Day 60
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN109.
Measured: From Day 1 to Day 60
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN109.
Measured: From Day 1 to Day 60
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN109.
Measured: From Day 1 to Day 60
Elimination Half-Life (t1/2)
t1/2 of MWN109.
Measured: From Day 1 to Day 60
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN109.
Measured: From Day 1 to Day 113
Steady State Minimum Concentration (Cmin,ss)
Cmin,ss of MWN109.
Measured: From Day 1 to Day 113
Steady State Concentration (Cav,ss)
Cav,ss of MWN109.
Measured: From Day 1 to Day 113
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN109.
Measured: From Day 1 to Day 113
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN109.
Measured: From Day 1 to Day 113
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
AUC0-τ,ss of MWN109.
Measured: From Day 1 to Day 113
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN109.
Measured: From Day 1 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start14 Jul 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT07787728
- Sponsor's protocol ID
- MWN109-Ⅰb
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Subcutaneous Administrations of MWN109 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07787728
- Acronym / sponsor ID
- MWN109-Ⅰb
- Conditions
- Overweight , Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 26 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 randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese non-diabetic participants with overweight or obesity.
A total of 40 participants were enrolled in the study. All participants were stratified and randomized by gender, and randomly assigned to 4 dose groups at a ratio of 1:1:1:1, with 10 participants in each group(8 participants received MWN109 injection, and 2 received placebo). Each treatment group will use a dose titration method to reach the target dose.
The study includes a maximum screening period of up to 2 weeks, a 14-week treatment period and a 2-week follow-up period, totaling 18 weeks. The primary endpoint is the incidence of adverse events. The secondary endpoint is the pharmacokinetic characteristics.
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 between 18 and 65 years old (inclusive of 18 and 65 years old), as determined by the date of signing the informed consent form.
- Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a BMI ranging from 27.0 to 35.0 kg/m2.
- Resting heart rate ≥ 55 beats per minute and ≤ 90 beats per minute (results of 12-lead electrocardiogram before randomization).
- Self-reported or documented weight change before the screening period of 12 weeks was less than 5.0%, and the participant can maintain their original diet and lifestyle during the trial period.
- Participants must have no pregnancy plans from the time of signing the informed consent form until 4 months after the last dose of the investigational drug.
Key exclusion criteria (19 listed)
- Individuals with a known allergy to GLP - 1 receptor agonist drugs or the excipient components of MWN109 injection, or those with severe allergic diseases or a severe allergic constitution at the time of screening.
- Used GLP-1 receptor agonists or similar drugs targeting the same site, drugs that affect body weight, or weight-loss drugs within 12 weeks before screening.
- Laboratory abnormalities: HbA1c ≥ 6.5%, or fasting blood glucose ≥ 7.0 mmol/L, or 2-hour blood glucose in the OGTT≥ 11.1 mmol/L (participants with fasting blood glucose between 6.1 and 6.9 mmol/L at the time of screening need to undergo the OGTT), ALT or AST ≥ 2.5ULN, or total serum bilirubin ≥ 1.5ULN. Serum amylase or serum lipase ≥ 1.5ULN. eGFR< 60 mL/min/1.73 m². Serum calcitonin level ≥ 35 ng/L (pg/mL). TSH> 6.0 mIU/L or < 0.4 mIU/L. Triglycerides ≥ 5.64 mmol/L (500 mg/dL). HGB< 110 g/L (for males) or < 100 g/L (for females).
- ECG shows second- or third-degree atrioventricular block, long QT syndrome (QTcF > 470 ms for females or > 450 ms for males), pre-excitation syndrome, or other ECG abnormalities that the investigator deems require drug intervention.
- Participants with a history or evidence of any of the following diseases:
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, 14 weeks | Drug | MWN109 Cohort 1 |
| MWN109 2Administered SC, QW, 14 weeks | Drug | MWN109 Cohort 2 |
| MWN109 3Administered SC, QW, 14 weeks | Drug | MWN109 Cohort 3 |
| MWN109 4Administered SC, QW, 14 weeks | Drug | MWN109 Cohort 4 |
| PlaceboAdministered SC, QW, 14 weeks | Drug | Placebo |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Day 1 to Day 113
Safety and tolerability assessed by the incidence of AEs and SAEs.
12 secondary outcomes
Maximum Concentration (Cmax)
Time frame: From Day 1 to Day 60
Time to Reach Maximum Concentration (Tmax)
Time frame: From Day 1 to Day 60
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: From Day 1 to Day 60
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: From Day 1 to Day 60
Elimination Half-Life (t1/2)
Time frame: From Day 1 to Day 60
Steady State Maximum Concentration (Cmax,ss)
Time frame: From Day 1 to Day 113
Steady State Minimum Concentration (Cmin,ss)
Time frame: From Day 1 to Day 113
Steady State Concentration (Cav,ss)
Time frame: From Day 1 to Day 113
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame: From Day 1 to Day 113
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame: From Day 1 to Day 113
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
Time frame: From Day 1 to Day 113
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
Time frame: From Day 1 to Day 113
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 Oct 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 1 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 19 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 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: From Day 1 to Day 113). 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 Oct 2026.