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

NCT06214741 | Completed Phase 3 FDA Drug

• 2 other identifiers: 1404-0061U1111-1295-9567
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 28

Brief 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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• 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

Study Arms (3)

survodutide 3.6 mg

EXPERIMENTAL

Drug: survodutide

survodutide 4.8 mg

EXPERIMENTAL

Drug: survodutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo matching BI 456906

Interventions

survodutide DRUG

once weekly subcutaneous injection

Also known as: BI 456906

survodutide 3.6 mg; survodutide 4.8 mg

Placebo matching BI 456906 DRUG

Once weekly subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥18 years at the time of signing informed consent.
• 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)
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• 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
• 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.

You may not qualify if:

• (A) Obesity:
• Body weight change (self-reported) \>5% within 3 months before screening.
• Treatment with any medication for the indication obesity within 3 months before screening.
• 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
• 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:
• New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (28)

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Pinggu Hospital

Beijing, 101200, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

The Second Hospital of Jilin University

Changchun, 130041, China

Location

Changzhou Second People's Hospital

Changzhou, 213004, China

Location

People's Hospital of Sichuan Province

Chengdu, 610072, China

Location

Second Affiliated Hospital Chongqing Medical University

Chongqing, 400016, China

Location

NanFang Hosptial

Guangzhou, 510515, China

Location

Forth Clinical Hospital of Harbin Medical University

Harbin, 150599, China

Location

Huzhou Central Hospital

Huzhou, 313000, China

Location

Center Hospital of Jinan

Jinan, 250013, China

Location

Jincheng General Hospital

Jincheng, 048000, China

Location

Lishui Municipal Central Hospital

Lishui, 323020, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, 471000, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210011, China

Location

Affiliated Hospital of Nantong University

Nantong, 226001, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, 315010, China

Location

Panjin Liao Oil Gem Flower Hospital

Panjin, 124000, China

Location

Shanghai Fifth People's Hospital affiliated to Fudan University

Shanghai, 200240, China

Location

Siping Central People's Hospital

Siping, 136000, China

Location

Tianjin Medical University Chu Hisen-I Memorial Hospital

Tianjin, 300070, China

Location

Tianjin Medical University General Hospital

Tianjin, 30052, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

The First Affiliated Hospital of Xi'an Medical University

Xi'an, 710077, China

Location

The People's Hospital Of Xuancheng City

Xuancheng, 242000, China

Location

Yichang Central People's Hospital

Yichang, 443000, China

Location

Yueyang People's Hospital

Yueyang, 414109, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Overweight

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 6, 2024
• Primary Completion: July 29, 2025
• Study Completion: January 28, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

CN (28)