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

A Phase III, Randomized, Double-blind, Parallel-group, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Chinese Participants With a BMI >=28 kg/m2 or BMI >=24 kg/m2 With at Least One Weight-related Complication

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: survodutide; Drug: Placebo matching BI 456906

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100020
    • Beijing Chao-Yang Hospital
  • Beijing, China, 101200
    • Beijing Pinggu Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changchun, China, 130041
    • The Second Hospital of Jilin University
  • Changzhou, China, 213004
    • Changzhou Second People's Hospital
  • Chengdu, China, 610072
    • People's Hospital of Sichuan Province
  • Chongqing, China, 400016
    • Second Affiliated Hospital Chongqing Medical University
  • Guangzhou, China, 510515
    • NanFang Hosptial
  • Harbin, China, 150599
    • Forth Clinical Hospital of Harbin Medical University
  • Huzhou, China, 313000
    • Huzhou Central Hospital
  • Jinan, China, 250013
    • Center Hospital of Jinan
  • Jincheng, China, 048000
    • Jincheng General Hospital
  • Lishui, China, 323020
    • Lishui Municipal Central Hospital
  • Luoyang, China, 471000
    • The First Affiliated Hospital of Henan University of Science and Technology
  • Nanjing, China, 210011
    • The Second Affiliated Hospital of Nanjing Medical University
  • Nantong, China, 226001
    • Affiliated Hospital of Nantong University
  • Ningbo, China, 315010
    • The First Affiliated Hospital of Ningbo University
  • Panjin, China, 124000
    • Panjin Liao Oil Gem Flower Hospital
  • Shanghai, China, 200240
    • Shanghai Fifth People's Hospital affiliated to Fudan University
  • Siping, China, 136000
    • Siping Central People's Hospital
  • Tianjin, China, 30052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300070
    • Tianjin Medical University Chu Hisen-I Memorial Hospital
  • Wuhan, China, 430022
    • Wuhan Union Hospital
  • Xi'an, China, 710077
    • The First Affiliated Hospital of Xi'an Medical University
  • Xuancheng, China, 242000
    • The People's Hospital Of Xuancheng City
  • Yichang, China, 443000
    • Yichang Central People's Hospital
  • Yueyang, China, 414109
    • Yueyang People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo matching BI 456906; Once weekly subcutaneous injection
Experimental: survodutide 3.6 mg	Drug: survodutide; once weekly subcutaneous injection; Other Names: BI 456906
Experimental: survodutide 4.8 mg	Drug: survodutide; once weekly subcutaneous injection; Other Names: BI 456906

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in body weight from baseline to Week 52	At baseline and at Week 52.
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52	At baseline and at Week 52.

Secondary Outcome Measures

Outcome Measure	Time Frame
Key secondary endpoint: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52	At baseline and at Week 52
Key secondary endpoint: Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 52	At baseline and at Week 52
Key secondary endpoint: Absolute change from baseline to Week 52 in waist circumference (cm)	At baseline and at Week 52
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52	At baseline and at Week 52
Absolute change from baseline to Week 52 in body weight (kg)	At baseline and at Week 52
Absolute change from baseline to Week 52 in glycosylated haemoglobin A1c (HbA1c) (%)	At baseline and at Week 52
Absolute change from baseline to Week 52 in HbA1c (mmol/mol)	At baseline and at Week 52
Absolute change from baseline to Week 52 in systolic blood pressure (SBP) (mmHg)	At baseline and at Week 52
Absolute change from baseline to Week 52 in diastolic blood pressure (DBP) (mmHg)	At baseline and at Week 52
Absolute change from baseline to Week 52 in body mass index (BMI) (kg/m^2)	At baseline and at Week 52
Absolute change from baseline to Week 52 in fasting plasma glucose (FPG) (mg/dL)	At baseline and at Week 52
Absolute change from baseline to Week 52 in fasting plasma insulin (FPI) (mIU/L)	At baseline and at Week 52
Absolute change from baseline to Week 52 in total cholesterol (mg/dL)	At baseline and at Week 52
Absolute change from baseline to Week 52 in triglycerides (mg/dL)	At baseline and at Week 52
Absolute change from baseline to Week 52 in free fatty acids (mg/dL)	At baseline and at Week 52
Absolute change from baseline to Week 52 in alanine aminotransferase (ALT) (U/L)	At baseline and at Week 52
Absolute change from baseline to Week 52 in aspartate aminotransferase (AST) (U/L)	At baseline and at Week 52
Absolute change from baseline to Week 52 in high-density lipoprotein (HDL) cholesterol (mg/dL)	At baseline and at Week 52
Absolute change from baseline to Week 52 in low-density lipoprotein (LDL) cholesterol (mg/dL)	At baseline and at Week 52
Absolute change from baseline to Week 52 in very low-density lipoprotein (VDL) cholesterol (mg/dL)	At baseline and at Week 52

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Actual): July 29, 2025
• Study Completion (Actual): January 28, 2026

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; BI 456906
• Other Study ID Numbers: 1404-0061; U1111-1295-9567 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes