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ObesityPhase 3NCT06214741

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

A Phase 3 study testing survodutide in people with Obesity and Overweight, run by Boehringer Ingelheim at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
survodutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
307 participants
Where
28 sitesChina
Study dates
6 Feb 2024to 28 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.
  • Further inclusion criteria apply.

Who cannot join

  • 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:
  • 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))
  • New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial
  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Pinggu Hospital

    Beijing, 101200

  • The First Hospital of Jilin University

    Changchun, 130021

  • The Second Hospital of Jilin University

    Changchun, 130041

  • Changzhou Second People's Hospital

    Changzhou, 213004

  • People's Hospital of Sichuan Province

    Chengdu, 610072

  • Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400016

  • NanFang Hosptial

    Guangzhou, 510515

  • Forth Clinical Hospital of Harbin Medical University

    Harbin, 150599

  • Huzhou Central Hospital

    Huzhou, 313000

  • Center Hospital of Jinan

    Jinan, 250013

  • Jincheng General Hospital

    Jincheng, 048000

  • Lishui Municipal Central Hospital

    Lishui, 323020

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

    Luoyang, 471000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010

  • Panjin Liao Oil Gem Flower Hospital

    Panjin, 124000

  • Shanghai Fifth People's Hospital affiliated to Fudan University

    Shanghai, 200240

  • Siping Central People's Hospital

    Siping, 136000

  • Tianjin Medical University Chu Hisen-I Memorial Hospital

    Tianjin, 300070

  • Tianjin Medical University General Hospital

    Tianjin, 30052

  • Wuhan Union Hospital

    Wuhan, 430022

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, 710077

  • The People's Hospital Of Xuancheng City

    Xuancheng, 242000

  • Yichang Central People's Hospital

    Yichang, 443000

  • Yueyang People's Hospital

    Yueyang, 414109

Other trials in China

About this study

Official title: 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.

Read more

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
Being tested
survodutide, Placebo matching BI 456906
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • survodutideDrug

    Also called BI 456906

    once weekly subcutaneous injection

  • Placebo matching BI 456906Drug

    Once weekly subcutaneous injection

Study groups in NCT06214741
Study groupRoleWhat they receive
survodutide 3.6 mgExperimentalNot described
Receives: Drug: survodutide
survodutide 4.8 mgExperimentalNot described
Receives: Drug: survodutide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo matching BI 456906

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At baseline and at Week 52.

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

    Measured: 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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

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

    Measured: At baseline and at Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start6 Feb 2024
  3. Primary completion29 Jul 2025
  4. Study completion28 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214741
Sponsor's protocol ID
1404-0061
Other IDs
U1111-1295-9567
Status last verified
Apr 2026
First submitted
10 Jan 2024
Last updated
30 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Ji L, Chen L, Cheng Z, Lu Y, Yang Y, Fu F, Zhu Y, Jin L, Kloer IM. Survodutide for Obesity in Chinese Adults: Phase 3 Randomized Trial Design and Baseline Characteristics (SYNCHRONIZE-CN). Diabetes Ther. 2026 Aug 14. doi: 10.1007/s13300-026-01908-x. Online ahead of print.

    PubMed 42599381

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing survodutide in people with Obesity and Overweight, run by Boehringer Ingelheim at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in body weight from baseline to Week 52 (time frame: At baseline and at Week 52.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06214741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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