Can a new injection help people shed significant weight?

NCT ID NCT07778693

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This phase 3 trial is testing whether an investigational injection called MWN109 can help non-diabetic adults with overweight or obesity lose weight. About 760 participants will receive either MWN109 or a placebo once a week for a year. The main goals are to see how much weight people lose and how many achieve at least a 5% reduction in body weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MWN109 injection
What this could lead to
If successful, MWN109 could offer a new medication option for weight loss in people with overweight or obesity, potentially improving health and reducing weight-related complications.
What could go wrong
This is an early-phase trial, so results may not confirm effectiveness or safety. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 760 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged 18 to 65 years (inclusive) at the time of signing the informed consent form; 2. Body weight ≥ 70 kg (males) or ≥ 60 kg (females), with BMI ≥ 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 ECG); 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 childbearing potential must agree to use highly effective contraception 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: 1. Known allergic constitution (allergy to 3 or more foods or drugs), or allergy to GLP-1 receptor agonists or any component of the investigational 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: ALT or AST ≥ 3×ULN; total bilirubin ≥ 1.5×ULN; eGFR \< 60 mL/min/1.73m²; hemoglobin \< 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 ECG abnormalities with significant safety risk, including: uncontrolled arrhythmias, second-degree or third-degree AV block, ST-T changes suggesting myocardial ischemia, QTcF \> 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: HbA1c ≥ 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; malignancy 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; autoimmune disease; previous or planned weight-loss treatment. 6. Pregnant or breastfeeding women. 7. Previous treatment with MWN109 injection.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, China

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