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Not yet recruitingNCT07779980Updated Aug 24, 2026

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

A Phase 1 interventional study of MWN110 and MWN110 in Overweight , Obesity, sponsored by Shanghai Minwei Biotechnology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Shanghai Minwei Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Overweight , Obesity
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. 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).
  3. 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.

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected allergy to the investigational product or its excipients, or history of severe allergy (including any food or drug allergy).
  2. 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%).
  3. Diagnosed with secondary overweight or obesity.
  4. History of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis); serum amylase or lipase above the upper limit of normal.
  5. Known history of disease or comorbidity affecting skeletal muscle protein.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Engaged in strenuous muscle exercise, high-intensity resistance training, or regular muscle-strengthening activities within 30 days before the first dose.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
103 participants (estimated)

Study arms

  • Experimental
    MWN110 S

    MWN110 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.

    Drug: MWN110 · Drug: Placebo

  • Experimental
    MWN110 MA

    MWN110 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.

    Drug: MWN110 · Drug: Placebo

  • Experimental
    MWN110 MB

    MWN110 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.

    Drug: MWN110 · Drug: Placebo

Interventions

  • DrugMWN110

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

  • DrugMWN110

    M1, M2; administered SC

  • DrugMWN110

    M3; administered SC

  • DrugPlacebo

    administered SC

05

What researchers measure

Primary outcomes

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

    Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: From Day 1 to Day 169

  2. Number of participants with abnormal vital signs

    Time frame: From Day 1 to Day 169

  3. Number of participants with abnormal ECG readings

    Time frame: From Day 1 to Day 169

  4. Number of participants with abnormal physical examination findings

    Time frame: From Day 1 to Day 169

  5. Number of participants with abnormal clinical laboratory measurements

    Time frame: From Day 1 to Day 169

  6. Number of participants with abnormal ophthalmological examination findings

    Time frame: From Day 1 to Day 169

Secondary outcomes

  1. Maximum Concentration (Cmax)

    Cmax of MWN110

    Time frame: From Day 1 to Day 57

  2. Time to Reach Maximum Concentration (Tmax)

    Tmax of MWN110

    Time frame: From Day 1 to Day 57

  3. Under the Concentration Versus Time Curve (AUC)

    Area AUC of MWN110

    Time frame: From Day 1 to Day 57

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

    t1/2 of MWN110

    Time frame: From Day 1 to Day 57

  5. Steady State Maximum Concentration (Cmax,ss)

    Cmax,ss of MWN110

    Time frame: From Day 1 to Day 169

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

    Tmax,ss of MWN110

    Time frame: From Day 1 to Day 169

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

    AUCss of MWN110

    Time frame: From Day 1 to Day 169

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

    t1/2,ss of MWN110

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: From Day 1 to Day 169

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

    Time frame: From Day 1 to Day 169

06

Study locations

1 site
  • The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
    Kunming, Yunnan, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07779980
Lead sponsor
Shanghai Minwei Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Aug 26, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 24, 2026

Study contacts

Wanxiang Chen
Contact
chenwanxiang@minweibiotech.com
13359015677

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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