A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
NCT ID: NCT06214741
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
307 participants
INTERVENTIONAL
2024-02-06
2026-01-30
Brief Summary
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Participants are put into 3 groups by chance. Each participant has an equal chance of being in each group. 2 groups get different doses of survodutide. 1 group gets placebo. Participants get survodutide or placebo as injections under the skin once a week for about 19 months.
Placebo injections look like survodutide injections but do not contain any medicine.
Participants are in the study for about 21 months. During this time, there are 20 visits. 14 visits are in person at the study site. Where possible, 6 visits can be done by video call, or by phone in rare cases. During this time, doctors regularly measure participant's body weight. Results are compared between the survodutide groups and placebo group to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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survodutide 3.6 mg
survodutide
once weekly subcutaneous injection
survodutide 4.8 mg
survodutide
once weekly subcutaneous injection
Placebo
Placebo matching BI 456906
Once weekly subcutaneous injection
Interventions
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survodutide
once weekly subcutaneous injection
Placebo matching BI 456906
Once weekly subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
6. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial
Exclusion Criteria
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:
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Beijing Chao-Yang Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing Pinggu Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Second Hospital of Jilin University
Changchun, , China
Changzhou Second People's Hospital
Changzhou, , China
People's Hospital of Sichuan Province
Chengdu, , China
Second Affiliated Hospital Chongqing Medical University
Chongqing, , China
NanFang Hosptial
Guangzhou, , China
Forth Clinical Hospital of Harbin Medical University
Harbin, , China
Huzhou Central Hospital
Huzhou, , China
Center Hospital of Jinan
Jinan, , China
Jincheng General Hospital
Jincheng, , China
Lishui Municipal Central Hospital
Lishui, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, , China
Affiliated Hospital of Nantong University
Nantong, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
Panjin Liao Oil Gem Flower Hospital
Panjin, , China
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, , China
Siping Central People's Hospital
Siping, , China
Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Wuhan Union Hospital
Wuhan, , China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, , China
The People's Hospital Of Xuancheng City
Xuancheng, , China
Yichang Central People's Hospital
Yichang, , China
Yueyang People's Hospital
Yueyang, , China
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1295-9567
Identifier Type: REGISTRY
Identifier Source: secondary_id
1404-0061
Identifier Type: -
Identifier Source: org_study_id