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New weekly shot shows promise for shedding pounds in obesity trial

NCT ID NCT06214741

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called survodutide in 307 Chinese adults with obesity or overweight. Participants received weekly injections of either survodutide or a placebo for about 19 months. The main goals were to see how much weight people lost and if at least 5% of body weight was reduced after one year. The study is complete, and results will show if survodutide is a safe and effective treatment for weight management.

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

307 people

The number who actually took part.

Started

Feb 2024

Finished

Jan 2026

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 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: 1. Male or female, age ≥18 years at the time of signing informed consent. 2. Body mass index (BMI) ≥28 kg/m\^2 at screening, OR BMI ≥24 kg/m\^2 at screening with the presence of at least one of the following weight-related complications: * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 mmHg and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high density lipoprotein (HDL) cholesterol \<40 mg/dL (\<1.0 mmol/L) for men or HDL cholesterol \<50 mg/dL (\<1.3 mmol/L) for women) * Obstructive sleep apnoea * Cardiovascular disease (CVD) (e.g. heart failure (HF) with New York Heart Association (NYHA) functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure \[e.g. carotid endarterectomy and/or stent\], myocardial infarction (MI), coronary artery disease, or peripheral vascular disease) * Type 2 diabetes mellitus (T2DM) diagnosed at least 180 days prior to screening (glycosylated haemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol), and fasting plasma glucose (FPG) ≤11.1 mmol/L measured by the central laboratory at screening \--- Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i) inhibitor, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label * Non-alcoholic steatohepatitis (NASH), as assessed in medical records by histological liver assessment (within the last 6 months) 3. History of at least one self-reported unsuccessful dietary effort to lose body weight 4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 5. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the participant information. Further inclusion criteria apply. Exclusion Criteria: (A) Obesity: 1. Body weight change (self-reported) \>5% within 3 months before screening. 2. Treatment with any medication for the indication obesity within 3 months before screening. 3. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the GI tract that could interfere with body weight The following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy 4. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) (B) Diabetes-related for participants with T2DM: 5. Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before screening (i.e. insulin, amylin analogues, glucagon-like peptide-1 receptor (GLP- 1R)) agonists, GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations, and dipeptidyl peptidase 4 inhibitor (DPP-4i)) 6. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial 7. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, verified by an eye examination within 3 months prior to screening or in the period between screening and randomisation Further exclusion criteria apply.

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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.

Obesity Overweight

Contacts and locations

Locations

  • Affiliated Hospital of Nantong University

    Nantong, 226001, China

  • Beijing Chao-Yang Hospital

    Beijing, 100020, China

  • Beijing Pinggu Hospital

    Beijing, 101200, China

  • Center Hospital of Jinan

    Jinan, 250013, China

  • Changzhou Second People's Hospital

    Changzhou, 213004, China

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599, China

  • Huzhou Central Hospital

    Huzhou, 313000, China

  • Jincheng General Hospital

    Jincheng, 048000, China

  • Lishui Municipal Central Hospital

    Lishui, 323020, China

  • NanFang Hosptial

    Guangzhou, 510515, China

  • Panjin Liao Oil Gem Flower Hospital

    Panjin, 124000, China

  • Peking University People's Hospital

    Beijing, 100044, China

  • People's Hospital of Sichuan Province

    Chengdu, 610072, China

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400016, China

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240, China

  • Siping Central People's Hospital

    Siping, 136000, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471000, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010, China

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The People's Hospital Of Xuancheng City

    Xuancheng, 242000, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011, China

  • The Second Hospital of Jilin University

    Changchun, 130041, China

  • Tianjin Medical University Chu Hisen-I Memorial Hospital

    Tianjin, 300070, China

  • Tianjin Medical University General Hospital

    Tianjin, 30052, China

  • Wuhan Union Hospital

    Wuhan, 430022, China

  • Yichang Central People's Hospital

    Yichang, 443000, China

  • Yueyang People's Hospital

    Yueyang, 414109, China

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