Overweight , ObesityPhase 1NCT07803809
Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity
A Phase 1 study testing MWN105 1, MWN105 2 and MWN105 3 in people with Overweight , Obesity and Type 2 Diabetes Mellitus (T2DM), 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, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- 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
- 36 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2026to Jan 2027
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants should be aged 18 to 50 years (inclusive, based on the date of signing the informed consent form) and be male or female, non-diabetic, overweight or obese individuals from China.
- Obese individuals: BMI ≥ 28.0 kg/m²; overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m², with or without the following: i. Complications including prediabetes (impaired fasting glucose and/or impaired glucose tolerance), hypertension, metabolic dysfunction-associated steatotic liver disease, or dyslipidemia; ii. Weight-bearing joint pain; iii. Breathing difficulties caused by obesity or obstructive sleep apnea syndrome.
- Female participants must have no plans for pregnancy or egg donation from 14 days before the first administration until 4 months after the last administration, and must voluntarily use effective contraception. Male participants must have no plans for sperm donation from the first administration until 4 months after the last administration and must voluntarily use effective contraception to prevent partner pregnancy.
Who cannot join
- Individuals with a history of severe drug allergy, concurrent severe allergic diseases, or a severe allergic constitution.
- Individuals with a history or evidence of any of the following:
- Secondary or drug-induced obesity.
- Type 1 or type 2 diabetes.
- Acute or chronic pancreatitis or pancreatic injury.
- Medullary thyroid carcinoma, MEN type 2A or 2B, or a related family history.
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- Prior gastric weight-loss surgery, or liposuction/fat removal surgery within one year before screening.
- Plans to undergo weight-loss surgery, liposuction, or abdominal fat removal surgery during the study period that would significantly affect body weight.
- History of depression or other serious mental illness, or history of suicidal ideation or behavior.
- History of malignant tumors.
- History of any of the following heart diseases within 6 months before screening: decompensated heart failure, unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; history of hemorrhagic or ischemic stroke within 6 months before screening, who were assessed by the investigator as unsuitable for the trial.
- Severe or recurrent symptomatic hypoglycemia within 6 months before screening.
- Untreated hypertension at screening that is not stabilized by treatment (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), or hypertension reaching these levels despite treatment at the time of screening.
- History of other severe endocrine system diseases affecting glucose metabolism.
- History of digestive system diseases that may increase participant risk, such as acute or chronic cholecystitis; symptomatic or treated cholelithiasis or gallbladder polyps at the time of screening; history of chronic gastrointestinal diseases; gastrointestinal surgery within 12 weeks before screening, who were assessed by the investigator as unsuitable for the trial.
- A history of infectious diseases, severe trauma, or major surgery within 4 weeks before screening, who were assessed by the investigator as unsuitable for the trial.
- Use of any of the following medications or treatments:
- Use of GLP-1 receptor agonists or drugs targeting the same target within 12 weeks prior to screening.
- Use of systemic glucocorticoids within 12 weeks prior to screening.
- Use of tricyclic antidepressants, psychiatric medications, or sedative drugs that significantly affect body weight within 12 weeks prior to screening.
- Use of prescription drugs for weight control within 12 weeks prior to screening.
- Use of over-the-counter drugs, health supplements, herbal preparations, or meal replacement products for weight control, appetite reduction, or as an alternative to diet within 12 weeks prior to screening, if used for a long-term period (continuous for ≥4 weeks or cumulative for ≥6 weeks).
- Use of acupuncture, physical therapy, or other non-drug treatments for weight loss within 12 weeks prior to screening.
- Regular use of drugs for gastrointestinal motility or drugs for irritable bowel syndrome, or use of any dosage of laxatives, within 4 weeks prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan
Jianchang He, Master of Pharmacy, +86 13700680697, Hejc@yn-cprc.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Administrations of MWN105 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity
This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants.
The study plans to enroll 36 male and female participants. Three dose groups were preset, with 12 participants in each. They were randomly assigned to receive MWN105 injection or placebo at a ratio of 5:1 and were administered the treatment in a titration manner, once a week, with a dose increase every two weeks until reaching the target dose. The administration lasted for 8 weeks.
The study consists of a 2-week screening period, an 8-week administration/observation period, and a 4-week follow-up period, totaling 14 weeks. The primary endpoint is the incidence of adverse events. Secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.
- Conditions
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Being tested
- MWN105 1, MWN105 2, MWN105 3, Placebo
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN105 1Drug
Administered SC, QW, 8 weeks
MWN105 2Drug
Administered SC, QW, 8 weeks
MWN105 3Drug
Administered SC, QW, 8 weeks
PlaceboDrug
Administered SC, QW, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| MWN105 Cohort 1 | Experimental | Not described Receives: Drug: MWN105 1; Drug: Placebo |
| MWN105 Cohort 2 | Experimental | Not described Receives: Drug: MWN105 2; Drug: Placebo |
| MWN105 Cohort 3 | Experimental | Not described Receives: Drug: MWN105 3; 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 78
Secondary outcomes (10)
Maximum Concentration (Cmax)
Cmax of MWN105.
Measured: From Day 1 to Day 78
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN105.
Measured: From Day 1 to Day 78
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN105.
Measured: From Day 1 to Day 78
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN105.
Measured: From Day 1 to Day 78
Elimination Half-Life (t1/2)
t1/2 of MWN105.
Measured: From Day 1 to Day 78
Change from baseline in body weight over time
Change in body weight from baseline to Day 78.
Measured: Baseline, Day 78
Change from baseline in body mass index (BMI) over time
Change in BMI from baseline to Day 78.
Measured: Baseline, Day 78
Change from baseline in waist circumference over time
Change in waist circumference from baseline to Day 78.
Measured: Baseline, Day 78
Change from baseline in lipid profile over time
Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to Day 78.
Measured: Baseline, Day 78
Detect anti-drug antibodies (ADA)
Measured: Baseline, Day 78
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 start26 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
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
- NCT07803809
- Sponsor's protocol ID
- MWN105-Ⅰc
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Administrations of MWN105 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07803809
- Acronym / sponsor ID
- MWN105-Ⅰc
- Conditions
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (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 is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants.
The study plans to enroll 36 male and female participants. Three dose groups were preset, with 12 participants in each. They were randomly assigned to receive MWN105 injection or placebo at a ratio of 5:1 and were administered the treatment in a titration manner, once a week, with a dose increase every two weeks until reaching the target dose. The administration lasted for 8 weeks.
The study consists of a 2-week screening period, an 8-week administration/observation period, and a 4-week follow-up period, totaling 14 weeks. The primary endpoint is the incidence of adverse events. Secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MWN105 Cohort 1 | Experimental | Drug: MWN105 1, Drug: Placebo |
| MWN105 Cohort 2 | Experimental | Drug: MWN105 2, Drug: Placebo |
| MWN105 Cohort 3 | Experimental | Drug: MWN105 3, Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants should be aged 18 to 50 years (inclusive, based on the date of signing the informed consent form) and be male or female, non-diabetic, overweight or obese individuals from China.
- Obese individuals: BMI ≥ 28.0 kg/m²; overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m², with or without the following: i. Complications including prediabetes (impaired fasting glucose and/or impaired glucose tolerance), hypertension, metabolic dysfunction-associated steatotic liver disease, or dyslipidemia; ii. Weight-bearing joint pain; iii. Breathing difficulties caused by obesity or obstructive sleep apnea syndrome.
- Female participants must have no plans for pregnancy or egg donation from 14 days before the first administration until 4 months after the last administration, and must voluntarily use effective contraception. Male participants must have no plans for sperm donation from the first administration until 4 months after the last administration and must voluntarily use effective contraception to prevent partner pregnancy.
Key exclusion criteria (24 listed)
- Individuals with a history of severe drug allergy, concurrent severe allergic diseases, or a severe allergic constitution.
- Individuals with a history or evidence of any of the following:
- Use of any of the following medications or treatments:
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, 8 weeks | Drug | MWN105 Cohort 1 |
| MWN105 2Administered SC, QW, 8 weeks | Drug | MWN105 Cohort 2 |
| MWN105 3Administered SC, QW, 8 weeks | Drug | MWN105 Cohort 3 |
| PlaceboAdministered SC, QW, 8 weeks | Drug | MWN105 Cohort 1, MWN105 Cohort 2, MWN105 Cohort 3 |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Day 1 to Day 78
Safety and tolerability assessed by the incidence of AEs and SAEs.
10 secondary outcomes
Maximum Concentration (Cmax)
Time frame: From Day 1 to Day 78
Time to Reach Maximum Concentration (Tmax)
Time frame: From Day 1 to Day 78
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: From Day 1 to Day 78
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: From Day 1 to Day 78
Elimination Half-Life (t1/2)
Time frame: From Day 1 to Day 78
Change from baseline in body weight over time
Time frame: Baseline, Day 78
Change from baseline in body mass index (BMI) over time
Time frame: Baseline, Day 78
Change from baseline in waist circumference over time
Time frame: Baseline, Day 78
Change from baseline in lipid profile over time
Time frame: Baseline, Day 78
Detect anti-drug antibodies (ADA)
Time frame: Baseline, Day 78
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 8 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.
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 MWN105 1, MWN105 2 and MWN105 3 in people with Overweight , Obesity and Type 2 Diabetes Mellitus (T2DM), 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 24 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: looking for participants now, as of the sponsor's last update on 8 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 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?
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?
Contact Wanxiang Chen (+86 13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. 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 78). 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 8 Sep 2026.