Skip to content

Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT06214741 (opens ClinicalTrials.gov in a new tab)Other id1404-0061Other idU1111-1295-9567

Overview

Status
Completed
Phase
Phase 3
Enrollment
307 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
6 Feb 2024
Primary completion
29 Jul 2025
Completion
28 Jan 2026
First posted
22 Jan 2024
Last update posted
30 Apr 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 3

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

    NCT06214741

    6 Feb 2024 to 28 Jan 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • survodutideDrug
  • Placebo matching BI 456906Drug

Arms3

  • Experimental

    survodutide 3.6 mg

  • Experimental

    survodutide 4.8 mg

  • Placebo comparator

    Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage change in body weight from baseline to Week 52

    Time frame · At baseline and at Week 52.

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

    Time frame · At baseline and at Week 52.

Secondary outcomes(20)
  1. Key secondary endpoint: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

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

    Time frame · At baseline and at Week 52

  11. Absolute change from baseline to Week 52 in fasting plasma glucose (FPG) (mg/dL)

    Time frame · At baseline and at Week 52

  12. Absolute change from baseline to Week 52 in fasting plasma insulin (FPI) (mIU/L)

    Time frame · At baseline and at Week 52

  13. Absolute change from baseline to Week 52 in total cholesterol (mg/dL)

    Time frame · At baseline and at Week 52

  14. Absolute change from baseline to Week 52 in high-density lipoprotein (HDL) cholesterol (mg/dL)

    Time frame · At baseline and at Week 52

  15. Absolute change from baseline to Week 52 in low-density lipoprotein (LDL) cholesterol (mg/dL)

    Time frame · At baseline and at Week 52

  16. Absolute change from baseline to Week 52 in very low-density lipoprotein (VDL) cholesterol (mg/dL)

    Time frame · At baseline and at Week 52

  17. Absolute change from baseline to Week 52 in triglycerides (mg/dL)

    Time frame · At baseline and at Week 52

  18. Absolute change from baseline to Week 52 in free fatty acids (mg/dL)

    Time frame · At baseline and at Week 52

  19. Absolute change from baseline to Week 52 in alanine aminotransferase (ALT) (U/L)

    Time frame · At baseline and at Week 52

  20. Absolute change from baseline to Week 52 in aspartate aminotransferase (AST) (U/L)

    Time frame · At baseline and at Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

PubMed tag: none · 2026

Survodutide for Obesity in Chinese Adults: Phase 3 Randomized Trial Design and Baseline Characteristics (SYNCHRONIZE™-CN).

Ji et al. 2026Diabetes therapy : research, treatment and education of diabetes and related disorders

PMID 42599381PMC13620080DOI 10.1007/s13300-026-01908-xPUB-42599381

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.