ClinicalTrials.gg
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.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Shanghai Minwei Biotechnology Co., Ltd (part of Lepu Medical) · Phase 1, Interventional, and Treatment

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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd — 6 open to participants now, 8 under way, 1 of them phase 3. Obesity · Shanghai Minwei Biotechnology Co., Ltd.

Planned enrollment
7th of 14
103 · median 88
Started
2026
with 6 others
Phase 1
8 of 14
5 open now
Registered
3rd of 14
by date

Among the 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd, this one is the 7th largest by planned enrollment, is one of 7 that started in 2026, is one of 8 in phase 1, and was the 3rd registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

Phase 1this study8 · 5 open
Phase 25 · 0 open
Phase 31 · 1 open

By the year they started

First in 2024; this study’s year is marked. 7 started in 2026.

Size and results

Median enrollment 88 across the 14 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd, or all of them as a file.
02

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).

03

Conditions studied

  • Overweight , Obesity

Browse trials for

04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 103 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Shanghai Minwei Biotechnology Co., Ltd is the lead sponsor of 21 studies on the registry; 10 are open to participants now.

First submitted after Shanghai Minwei Biotechnology Co., Ltd became part of Lepu Medical.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female participants aged 18 to 65 years (inclusive) at the time of signing the 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; (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 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 product or its , 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 .
  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) , aspartate aminotransferase, or total >1.5 × upper limit of normal (ULN); c) estimated \<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) \<100 g/L (females) or \<110 g/L (males); f) blood uric acid (UA) >540 μmol/L.
  9. At screening, 12-lead showing heart rate \<50 bpm or >100 bpm, second-degree or third-degree atrioventricular block, long 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 (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.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

06

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

07

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

08

Study locations

1 site
  • The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
    Kunming, Yunnan, China
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07779980
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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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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