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Overweight , ObesityPhase 1NCT07779980

Phase 1 Clinical Study of MWN110 Injection in Healthy Participants and Overweight or Obese Participants

A Phase 1 study testing MWN110 in people with Overweight , Obesity, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight , Obesity
What is being tested?
MWN110
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteChina
Study dates
26 Aug 2026to Aug 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • 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); the proportion of either gender shall not be less than 1/3.
  • Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 20.0 to 40.0 kg/m^2 (inclusive).
  • Female participants must have no plans for pregnancy or egg donation from 14 days before the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid pregnancy; male participants must have no plans for fathering a child or sperm donation from the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid causing partner pregnancy.

Who cannot join

  • Known or suspected allergy to the investigational product or its excipients, or history of severe allergy (including any food or drug allergy).
  • Body weight change >5% within 3 months prior to screening (weight change % = [maximum weight in 3 months - minimum weight in 3 months] / maximum weight in 3 months x 100%).
  • Diagnosed with secondary overweight or obesity.
  • History of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis); serum amylase or lipase above the upper limit of normal.
  • Known history of disease or comorbidity affecting skeletal muscle protein.
  • At screening, the presence of active acne, pyogenic dermatosis, allergic dermatosis, inflammatory dermatosis, infectious dermatosis, unhealed skin wounds, extensive skin lesions, or skin abnormalities such as vegetations or masses, judged by the investigator as unsuitable for participation.
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  • History of infectious disease within 4 weeks prior to screening (judged by the investigator as potentially significantly affecting safety evaluation), history of severe trauma, or history of major surgery within 3 months, or planned surgery during the study period.
  • At screening, any laboratory test meeting any of the following criteria: a) fasting blood glucose >6.1 mmol/L or <3.9 mmol/L; b) alanine aminotransferase, aspartate aminotransferase, or total bilirubin >1.5 × upper limit of normal (ULN); c) estimated glomerular filtration rate <70 mL/min/1.73 m² (CKD-EPI equation) or urinary protein positive (1+ or above); d) fasting triglycerides ≥3.42 mmol/L (Part 1) or >5.64 mmol/L (Part 2); e) hemoglobin <100 g/L (females) or <110 g/L (males); f) blood uric acid (UA) >540 μmol/L.
  • At screening, 12-lead electrocardiogram showing heart rate <50 bpm or >100 bpm, second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF >460 ms (female) or >450 ms (male), or other electrocardiogram abnormalities judged by the investigator as requiring pharmacological intervention.
  • Participants who have undergone dieting or weight-loss treatment within 30 days prior to the first dose, or who have experienced major changes in lifestyle habits.
  • Use of GLP-1 receptor agonists, weight-loss drugs, systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months before the first dose.
  • Engaged in strenuous muscle exercise, high-intensity resistance training, or regular muscle-strengthening activities within 30 days before the first dose.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wanxiang Chen contact

13359015677

chenwanxiang@minweibiotech.com

China1 site

  • The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

    Kunming, Yunnan

    Jianchang He, Master of Pharmacy, 13700680697, hejc@yn-cprc.com

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Administrations of MWN110 Injection in Healthy Participants and Overweight or Obese Participants

This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants.

The study consists of two parts: Part 1, a single ascending dose (SAD) study in healthy participants with 8 dose cohorts; and Part 2, a multiple ascending dose (MAD) study in overweight or obese participants with 3 dose cohorts, with a dosing frequency of once weekly or once every 4 weeks.

Approximately 103 participants will be enrolled. The primary endpoint is safety and tolerability, assessed by adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and ophthalmic examination. Secondary endpoints include single-dose and multiple-dose PK parameters, PD parameters (body weight, BMI, waist circumference, muscle mass, body fat percentage, visceral fat, subcutaneous fat, bone mineral density), and immunogenicity (anti-drug antibodies).

Being tested
MWN110, 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.

  • MWN110Drug

    S1, S2, S3, S4, S5, S6, S7, S8; administered subcutaneously (SC)

  • MWN110Drug

    M1, M2; administered SC

  • MWN110Drug

    M3; administered SC

  • PlaceboDrug

    administered SC

Study groups in NCT07779980
Study groupRoleWhat they receive
MWN110 SExperimentalMWN110 Cohort S consists of 8 dose groups, with doses ranging from 15 mg to 1200 mg. Healthy participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN110 or placebo.
Receives: Drug: MWN110; Drug: Placebo
MWN110 MAExperimentalMWN110 Cohort MA consists of 2 dose groups, with specific doses to be determined based on results from MWN110 Cohort S. In all dose groups, overweight or obese participants are randomized to receive 5 subcutaneous doses of MWN110 or placebo, administered once weekly.
Receives: Drug: MWN110; Drug: Placebo
MWN110 MBExperimentalMWN110 Cohort MB consists of 1 dose group, with the specific dose to be determined based on results from MWN110 Cohort S. In this dose group, overweight or obese participants are randomized to receive 2 subcutaneous doses of MWN110 or placebo, administered every 4 weeks.
Receives: Drug: MWN110; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) to the investigational product

    Incidence of treatment-emergent adverse events (TEAEs)

    Measured: From Day 1 to Day 169

  2. Number of participants with abnormal vital signs

    Measured: From Day 1 to Day 169

  3. Number of participants with abnormal ECG readings

    Measured: From Day 1 to Day 169

  4. Number of participants with abnormal physical examination findings

    Measured: From Day 1 to Day 169

  5. Number of participants with abnormal clinical laboratory measurements

    Measured: From Day 1 to Day 169

  6. Number of participants with abnormal ophthalmological examination findings

    Measured: From Day 1 to Day 169

Secondary outcomes (14)

  1. Maximum Concentration (Cmax)

    Cmax of MWN110

    Measured: From Day 1 to Day 57

  2. Time to Reach Maximum Concentration (Tmax)

    Tmax of MWN110

    Measured: From Day 1 to Day 57

  3. Under the Concentration Versus Time Curve (AUC)

    Area AUC of MWN110

    Measured: From Day 1 to Day 57

  4. Apparent Terminal Elimination Half-life (t1/2)

    t1/2 of MWN110

    Measured: From Day 1 to Day 57

  5. Steady State Maximum Concentration (Cmax,ss)

    Cmax,ss of MWN110

    Measured: From Day 1 to Day 169

  6. Time to Reach Maximum Concentration at Steady State (Tmax,ss)

    Tmax,ss of MWN110

    Measured: From Day 1 to Day 169

  7. Steady State Area Under the Concentration Versus Time Curve (AUCss)

    AUCss of MWN110

    Measured: From Day 1 to Day 169

  8. Steady State Apparent Terminal Elimination Half-life (t1/2,ss)

    t1/2,ss of MWN110

    Measured: From Day 1 to Day 169

  9. Change from Baseline in Body Weight

    Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.

    Measured: From Day 1 to Day 169

  10. Change from Baseline in Body Mass Index (BMI)

    Change from baseline in BMI is calculated by subtracting the baseline BMI value from the post-treatment BMI value at a specified time point.

    Measured: From Day 1 to Day 169

  11. Change from Baseline in Waist Circumference

    Change from baseline in waist circumference is calculated by subtracting the baseline waist measurement from the post-treatment waist measurement at a specified time point.

    Measured: From Day 1 to Day 169

  12. Change from Baseline in Muscle Mass

    Change from baseline in muscle mass is calculated by subtracting the baseline muscle mass measurement from the post-treatment muscle mass measurement at a specified time point.

    Measured: From Day 1 to Day 169

  13. Change from Baseline in Body Fat Percentage (BFP)

    Change from baseline in BFP is calculated by subtracting the baseline BMI value from the post-treatment BFPvalue at a specified time point.

    Measured: From Day 1 to Day 169

  14. Incidence and Titers of Anti-drug Antibody (ADA)

    Measured: From Day 1 to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start26 Aug 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779980
Sponsor's protocol ID
MWN110-101
Status last verified
Aug 2026
First submitted
14 Aug 2026
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MWN110 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 12 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: opening soon, as of the sponsor's last update on 24 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. 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 (13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) to the investigational product (time frame: From Day 1 to Day 169). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07779980.

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 24 Aug 2026.

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