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New study tests combo of low-dose drug and lifestyle to stop weight regain

NCT ID NCT07517042

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tests whether a low dose of the weight-loss drug mazdutide, an intensive lifestyle program, or both can help people with obesity maintain weight loss for a year after initially losing weight with a higher drug dose. About 420 adults with a BMI between 28 and 45 will take part. The goal is to find a safe and effective long-term strategy for weight maintenance.

What this could mean

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

Active substance
Mazdutide (a weight-loss drug given as a weekly injection)
What this could lead to
If successful, this could show a practical way to maintain weight loss long-term using a lower drug dose, lifestyle changes, or both, reducing the need for high-dose medication.
What could go wrong
This is an early-stage study with no phase designation, and it only looks at weight maintenance over one year. The low drug dose may not be enough for everyone, and lifestyle changes can be hard to stick with.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 420 people

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

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Adult men or women aged 18 years or older; * Simple obesity, defined as a body mass index (BMI) of 28.0-45.0 kg/m²; * Able and willing to provide written informed consent. Exclusion Criteria: * Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases; * Severe hepatic impairment (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>3 times the upper limit of normal), severe renal impairment, or end-stage renal disease (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²); * Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months; * Severe gastrointestinal diseases, or a history of gastrointestinal resection surgery within the past year; * Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury; * Obesity secondary to other causes, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, or acromegaly; drug-induced obesity, such as obesity related to the use of antipsychotic agents or glucocorticoids; * Current smoker or habitual smoking within the past 3 months; * Current use of other weight-loss medications or a history of bariatric surgery; * Previously diagnosed diabetes mellitus or current use of glucose-lowering medications; * Pregnant or breastfeeding women, or women planning pregnancy during the study period; * Inability to complete a 2-year follow-up due to health conditions, relocation, or other reasons; * Any other condition deemed by the investigator to make the participant unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

Motor Activity Obesity obesity disorder

As listed by the trial registrant

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

Obesity Weight control

How to take part

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

  1. The places running it

    13 sites. 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

  • Fujian Provincial Hospital, Affiliated to Fuzhou University

    RECRUITING

    Fuzhou, Fujian, 350000, China

  • Huadong Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Nanjing First Hospital, Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Shanghai Tenth People's Hospital, School of Medicine, Tongji University

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • The Affiliated Hospital of Southwest Medical University

    RECRUITING

    Luzhou, Sichuan, 646000, China

  • The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University

    RECRUITING

    Suzhou, Jiangsu, 215000, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400000, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

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