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

Last updated: June 10, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Placebo matching BI 456906

BI 456906

survodutide

Clinical Study ID

NCT06214741
1404-0061
U1111-1295-9567
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 withthe presence of at least one of the following weight-related complications:

  • Hypertension (defined as repeated, i.e. at least 3 measurements in restingcondition, systolic blood pressure (SBP) values of ≥140 mmHg and/or diastolicblood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensivetreatment, or intake of at least 1 anti-hypertensive drug to maintain anormotensive blood pressure)

  • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required tomaintain normal blood lipid levels, or low density lipoprotein (LDL)cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7mmol/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 HeartAssociation (NYHA) functional class II-III, history of ischaemic orhaemorrhagic stroke or cerebrovascular revascularisation procedure [e.g.carotid endarterectomy and/or stent], myocardial infarction (MI), coronaryartery 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% (86mmol/mol), and fasting plasma glucose (FPG) ≤11.1 mmol/L measured by thecentral 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-glucosecotransporter-2 inhibitor (SGLT2i) inhibitor, acarbose, sulfonylurea, orglitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to locallabel

  • Non-alcoholic steatohepatitis (NASH), as assessed in medical records byhistological liver assessment (within the last 6 months)

  1. History of at least one self-reported unsuccessful dietary effort to lose bodyweight

  2. Signed and dated written informed consent in accordance with International Councilfor Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-GoodClinical Practice (ICH-GCP) and local legislation prior to admission to the trial

  3. Woman of childbearing potential (WOCBP) must be ready and able to use highlyeffective methods of birth control per ICH M3 (R2) that result in a low failure rateof less than 1% per year when used consistently and correctly. A list ofcontraception methods meeting these criteria and instructions on the duration oftheir use will be provided in the participant information.

Further inclusion criteria apply.

Exclusion

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 beforescreening.

  3. Previous or planned (during the trial period) treatment for obesity with surgery ora weight loss device, or prior surgery of the GI tract that could interfere withbody weight The following are allowed: (1) liposuction and/or abdominoplasty, ifperformed >1 year before screening, (2) lap banding, if the band has been removed >1year before screening, (3) intragastric balloon, if the balloon has been removed >1year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has beenremoved >1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7)cholecystectomy

  4. Have obesity induced by other endocrinologic disorders (for example, CushingSyndrome) 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 theinclusion criteria within 3 months before screening (i.e. insulin, amylin analogues,glucagon-like peptide-1 receptor (GLP- 1R)) agonists, GLP-1Ragonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations, anddipeptidyl peptidase 4 inhibitor (DPP-4i))

  6. New initiation of any other glucose-lowering investigational drug within 3 monthsprior to screening for this trial

  7. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, verifiedby an eye examination within 3 months prior to screening or in the period betweenscreening and randomisation Further exclusion criteria apply.

Study Design

Total Participants: 307
Treatment Group(s): 3
Primary Treatment: Placebo matching BI 456906
Phase: 3
Study Start date:
February 06, 2024
Estimated Completion Date:
January 30, 2026

Connect with a study center

  • Beijing Chao-Yang Hospital

    Beijing, 100020
    China

    Site Not Available

  • Beijing Pinggu Hospital

    Beijing, 101200
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, 100044
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun, 130041
    China

    Site Not Available

  • Changzhou Second People's Hospital

    Changzhou, 213004
    China

    Site Not Available

  • People's Hospital of Sichuan Province

    Chengdu, 610072
    China

    Site Not Available

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400016
    China

    Site Not Available

  • NanFang Hosptial

    Guangzhou, 510515
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Hangzhou, 210011
    China

    Site Not Available

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599
    China

    Site Not Available

  • Huzhou Central Hospital

    Huzhou, 313000
    China

    Site Not Available

  • Center Hospital of Jinan

    Jinan, 250013
    China

    Site Not Available

  • Jincheng General Hospital

    Jincheng, 048000
    China

    Site Not Available

  • Lishui Municipal Central Hospital

    Lishui, 323020
    China

    Site Not Available

  • Luoyang Third People's Hospital

    Luoyang, 471002
    China

    Site Not Available

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

    Luoyang, 471000
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong, 226001
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010
    China

    Site Not Available

  • Panjin Liao Oil Gem Flower Hospital

    Panjin, 124000
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, 337000
    China

    Site Not Available

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240
    China

    Site Not Available

  • Siping Central People's Hospital

    Siping, 136000
    China

    Site Not Available

  • Tianjin Medical University Chu Hisen-I Memorial Hospital

    Tianjin, 300070
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 30052
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077
    China

    Site Not Available

  • The People's Hospital Of Xuancheng City

    Xuancheng, 242000
    China

    Site Not Available

  • Yichang NO.1 People's Hospital

    Yichang, 443000
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004
    China

    Site Not Available

  • Yueyang People's Hospital

    Yueyang, 414109
    China

    Site Not Available

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