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Not yet recruitingNCT07778693Updated Aug 21, 2026

Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity

A Phase 3 interventional study of MWN109 1 and MWN109 2 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. Per ClinicalTrials.gov, last updated 2026-08-21.

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 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
760
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
Largest of 14
760 · median 88
Started
2026
with 6 others
Phase 3
Only one
of the 14
Registered
4th of 14
by date

Among the 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd, this one has the largest planned enrollment, is one of 7 that started in 2026, is the only one in phase 3, and was the 4th registered.

By phase

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

Phase 18 · 5 open
Phase 25 · 0 open
Phase 3this study1 · 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 is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity.

Approximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose.

The study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.

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 760 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
No

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 aged 18 to 65 years (inclusive) at the time of signing the form;
  2. Body weight ≥ 70 kg (males) or ≥ 60 kg (females), with ≥ 28 kg/m² (obesity), or 24 kg/m² ≤ BMI \< 28 kg/m² (overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, polycystic ovary syndrome);
  3. Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead );
  4. Self-reported or documented history of dietary and exercise-based weight management for at least 12 weeks prior to screening, with \< 5.0% weight change during the 12 weeks prior to screening, and ability to maintain the required diet and exercise behavior during the study;
  5. Participants of must agree to use highly effective from 14 days before signing the ICF until 4 months after the last dose, with no plans for pregnancy or oocyte donation; male participants must agree to use highly effective contraception from signing the ICF until 4 months after the last dose, with no plans for fathering children or sperm donation.

Exclusion criteria

Exclusion Criteria:

  1. Known allergic constitution (allergy to 3 or more foods or drugs), or allergy to GLP-1 receptor agonists or any component of the product, or severe allergic diseases at screening, or history of severe drug allergy.
  2. Use of any anti-hyperglycemic agents, weight-affecting medications, or prescription weight-loss medications for weight control within 12 weeks prior to screening; over-the-counter weight-loss medications or appetite suppressants within 4 weeks.
  3. Laboratory abnormalities: or AST ≥ 3×; total ≥ 1.5×ULN; \< 60 mL/min/1.73m²; \< 110 g/L (males) or \< 100 g/L (females); serum calcitonin ≥ 35 ng/L; TSH > 6.0 or \< 0.4 mIU/L; fasting triglycerides ≥ 5.64 mmol/L; serum amylase or lipase > 2.0×ULN.
  4. Known or screening-detected abnormalities with significant safety risk, including: uncontrolled arrhythmias, second-degree or third-degree AV block, ST-T changes suggesting myocardial ischemia, > 450 ms, family history of long QT or Brugada syndrome.
  5. Has a medical history or evidence of any of the following conditions: secondary or drug-induced overweight or obesity; diagnosis of type 1 or type 2 diabetes mellitus in the past or at screening, or at least one laboratory finding suggestive of diabetes identified at screening: ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol/L, random plasma glucose ≥ 11.1 mmol/L, or 2-hour plasma glucose during the oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L; acute or chronic pancreatitis; gallstones/cholecystitis (with exceptions); thyroid C-cell carcinoma or MEN 2A/2B; prior bariatric surgery (with exceptions); moderate or severe depression (PHQ-9 ≥ 15), other severe psychiatric disorders, or suicidal risk; within 5 years (with exceptions); cardiac disease within 6 months; premature beats or tachycardia; cerebrovascular event within 6 months; uncontrolled hypertension; thyroid dysfunction; gastric emptying abnormalities; organ transplant history; disease; previous or planned weight-loss treatment.
  6. Pregnant or breastfeeding women.
  7. Previous treatment with MWN109 injection.
Terms in these criteria, in plain language(15)

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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

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.

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.

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).

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.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

06

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
760 participants (estimated)

Study arms

  • Experimental
    MWN109 Cohort 1

    Drug: MWN109 1

  • Experimental
    MWN109 Cohort 2

    Drug: MWN109 2

  • Experimental
    MWN109 Cohort 3

    Drug: MWN109 3

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Administered SC, QW, 52 weeks

  • Administered SC, QW, 52 weeks

  • Administered SC, QW, 52 weeks

  • DrugPlacebo

    Administered SC, QW, 52 weeks

07

What researchers measure

Primary outcomes

  1. Percentage Change from Baseline in Body Weight at Week 52

    Percentage change in body weight from baseline to Week 52.

    Time frame: Baseline, Week 52

  2. Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 52

    Proportion of participants with a body weight reduction of 5% or more from baseline at Week 52.

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 52

    Proportion of participants with a body weight reduction of 10% or more from baseline at Week 52.

    Time frame: Baseline, Week 52

  2. Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 52

    Proportion of participants with a body weight reduction of 15% or more from baseline at Week 52.

    Time frame: Baseline, Week 52

  3. Change in Waist Circumference from Baseline at Week 52

    Change in waist circumference from baseline to week 52.

    Time frame: Baseline, Week 52

  4. Change from Baseline in Waist-to-Height Ratio (WHtR)

    Change in WHtR from baseline throughout the study.

    Time frame: up to 52 weeks

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

    Change in BMI from baseline throughout the study.

    Time frame: up to 52 weeks

  6. Change from Baseline in Neck Circumference

    Change in neck circumference from baseline throughout the study.

    Time frame: up to 52 weeks

  7. Change from Baseline in Blood Lipid Parameters

    Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study.

    Time frame: up to 52 weeks

  8. Change from Baseline in Blood Pressure

    Change in systolic and diastolic blood pressure from baseline throughout the study.

    Time frame: up to 52 weeks

  9. Change from Baseline in Glucose Metabolism Parameters

    Change in glucose metabolism parameters (including fasting plasma glucose, HbA1c, fasting insulin, HOMA-IR) from baseline throughout the study.\]

    Time frame: up to 52 weeks

  10. Change from Baseline in Serum Uric Acid

    Change in serum uric acid from baseline throughout the study.

    Time frame: up to 52 weeks

  11. Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR)

    Change in UACR from baseline throughout the study.

    Time frame: up to 52 weeks

  12. Change in Liver Fat Content (LFC) from Baseline at Week 52

    Change in LFC from baseline to week 52.

    Time frame: up to 52 weeks

  13. Change in IWQOL-Lite-CT Score from Baseline at Week 24 and Week 52

    Change in IWQOL-Lite-CT score from baseline to Week 24 and Week 52.

    Time frame: Baseline, Week 24, Week 52

  14. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Number and proportion of participants with treatment-emergent adverse events throughout the study.

    Time frame: up to 52 weeks

08

Study locations

1 site
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07778693
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 21, 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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Studies of the drug tested here: MWN109

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