Current partner codePEPTIDESDE
NCT06214741·Phase 3·INTERVENTIONAL

A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight

Status

Completed

Phase

Phase 3

Enrollment

307

Locations

28

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study in China is open to adults who are at least 18 years old who are living with overweight or obesity. People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study. The main purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity. 2 different doses of survodutide are tested in this study. 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.

Interventions

Treatment arms and agents.

DRUG

survodutide

once weekly subcutaneous injection

DRUG

Placebo matching BI 456906

Once weekly subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Jan 22, 2024

  2. Study start

    Feb 6, 2024

  3. Primary completion

    Jul 29, 2025

  4. Study completion

    Jan 28, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 30, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage change in body weight from baseline to Week 52

Time frame · At baseline and at Week 52.

Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52

Time frame · At baseline and at Week 52.

Secondary outcomes

Key secondary endpoint: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52

Time frame · At baseline and at Week 52

Key secondary endpoint: Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 52

Time frame · At baseline and at Week 52

Key secondary endpoint: Absolute change from baseline to Week 52 in waist circumference (cm)

Time frame · At baseline and at Week 52

Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52

Time frame · At baseline and at Week 52

Absolute change from baseline to Week 52 in body weight (kg)

Time frame · At baseline and at Week 52

Absolute change from baseline to Week 52 in glycosylated haemoglobin A1c (HbA1c) (%)

Time frame · At baseline and at Week 52

Absolute change from baseline to Week 52 in HbA1c (mmol/mol)

Time frame · At baseline and at Week 52

Absolute change from baseline to Week 52 in systolic blood pressure (SBP) (mmHg)

Time frame · At baseline and at Week 52

Absolute change from baseline to Week 52 in diastolic blood pressure (DBP) (mmHg)

Time frame · At baseline and at Week 52

Absolute change from baseline to Week 52 in body mass index (BMI) (kg/m^2)

Time frame · At baseline and at Week 52

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

28 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.