Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 50

MWN105 injection in overweight or obese adults you may join

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

Run by Shanghai Minwei Biotechnology Co., Ltd · NCT07803809 · Data updated 2026-11-12

This early-phase trial tests whether MWN105 is safe and tolerable in overweight or obese adults in China, using a placebo comparison.

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Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 50 Years
SexAll
Enrollment36 (estimated)
SponsorShanghai Minwei Biotechnology Co., Ltd
Industry-sponsored
Locations1 site (Kunming, Yunnan)
StatusRecruiting
StartedApril 26, 2026
Main results expectedOctober 2026
Study endsJanuary 2027
Registry record updatedSeptember 8, 2026
Trial IDNCT07803809 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Chinese adults 18–50 years old who are overweight or obese (BMI ≥24) and non-diabetic, with or without metabolic complications, and willing to use contraception as required.

Probably not a fit

Participants without obesity-related conditions, those with certain health issues or who cannot participate in injections may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 across three dose levels in adults aged 18–50 who are overweight or have obesity. Participants are assigned to one of three MWN105 dose groups or placebo in a 5:1 ratio, with weekly administrations and planned dose escalations over 8 weeks, followed by 4 weeks of follow-up. The study includes a 2-week screening, 8-week treatment/observation, and 4-week follow-up, totaling 14 weeks. Primary endpoint focuses on adverse events; secondary endpoints examine pharmacokinetics, pharmacodynamics, and immunogenicity.

Why it matters

Potential benefit: If successful, MWN105 could provide a new option for weight-related health management in overweight or obese adults.

How similar studies have gone: Other early-phase weight management therapies have shown safety signals in similar dose-escalation designs, supporting the approach but with variable outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. 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.
2. 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.
3. 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.

Exclusion Criteria:

1. Individuals with a history of severe drug allergy, concurrent severe allergic diseases, or a severe allergic constitution.
2. 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.
   * 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.
3. 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.

Where it's running

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

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.