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Trial · Interventional

CompletedPhase 3Registry data

A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease

Short name SYNCHRONIZE™JP

NCTNCT06176365 (opens ClinicalTrials.gov in a new tab)Other id1404-0053
Open at ClinicalTrials.govAsk about this trial

Overview

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

Japan

Start
16 Jan 2024
Primary completion
3 Dec 2025
Completion
3 Dec 2025
First posted
19 Dec 2023
Last update posted
30 Apr 2026
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 3

    SYNCHRONIZE™JP

    NCT06176365

    16 Jan 2024 to 3 Dec 2025

Registry summary

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

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or * a BMI of 27 kg/m² or more and at least two health problems related to their weight. People who have either type 2 diabetes, high blood pressure, or increased blood lipids can take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesity disease to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

Interventions

  • SurvodutideDrug
  • Placebo matching survodutideDrug

Arms3

  • Experimental

    Survodutide - 3.6 mg

  • Experimental

    Survodutide - 6.0 mg

  • Placebo comparator

    Placebo group

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage change in body weight from baseline to Week 76

    Time frame · at baseline, at week 76

  2. Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

    Time frame · at baseline, at week 76

Secondary outcomes(20)

  1. Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76

    Time frame · at baseline, at week 76

  2. Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76

    Time frame · at baseline, at week 76

  3. Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76

    Time frame · at baseline, at week 76

  4. Absolute change from baseline to Week 76 in body weight (kg)

    Time frame · at baseline, at week 76

  5. Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²)

    Time frame · at baseline, at week 76

  6. Absolute change from baseline to Week 76 in waist circumference measured at umbilical level (cm)

    Time frame · at baseline, at week 76

  7. Absolute change from baseline to Week 76 in waist circumference measured at midway between the lower rib margin and the iliac crest (cm)

    Time frame · at baseline, at week 76

  8. Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)

    Time frame · at baseline, at week 76

  9. Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)

    Time frame · at baseline, at week 76

  10. Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour Patient reported outcome (PRO)

    Time frame · at baseline, at week 76

    Registry description

    The "Capacity to Resist domain score" of the Eating Behaviour Patient reported outcome (PRO) (units on a scale) will be derived as the sum of items in the domain (possible responses being 0="Not at all", 1="A little", 2="Moderately", 3="A lot", 4="Extremely"). The domain score is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.

  11. Absolute change from baseline to Week 76 in Eating Behaviour PRO total score

    Time frame · at baseline, at week 76

    Registry description

    The Eating Behaviour PRO total score (units on a scale) will be derived from the "Desire to Eat" and "Capacity to Resist" domain as the sum of all items (possible responses being 0="Not at all", 1="A little", 2="Moderately", 3="A lot", 4="Extremely"). Each domain consists of 6 items. The score is ranging between 0 and 48 and a higher score indicates a worse eating behaviour (greater desire to eat and/or lower capacity to resist).

  12. Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)

    Time frame · at baseline, at week 76

  13. Absolute change from baseline to Week 76 in HbA1c (mmol/mol)

    Time frame · at baseline, at week 76

  14. Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)

    Time frame · at baseline, at week 76

  15. Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)

    Time frame · at baseline, at week 76

  16. Absolute change from baseline to Week 76 in total cholesterol (mg/dL)

    Time frame · at baseline, at week 76

  17. Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)

    Time frame · at baseline, at week 76

  18. Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)

    Time frame · at baseline, at week 76

  19. Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)

    Time frame · at baseline, at week 76

  20. Absolute change from baseline to Week 76 in triglycerides (mg/dL)

    Time frame · at baseline, at week 76

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

Indexing hint: Clinical trial · 2026

Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics of the Phase 3 SYNCHRONIZE-JP Trial.

Yokote et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42219222PMC13341362DOI 10.1111/dom.70862PUB-42219222

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) * ≥35 kg/m² at screening with the presence of at least one obesity-related comorbidities (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline OR * BMI ≥27 kg/m² at screening with the presence of at least two obesity-related comorbidities (treated or untreated) according to the JASSO guideline For all trial patients, at least one co-morbidity should be the following (i)-(iii). i. Type 2 diabetes mellitus (T2DM) * Diagnosed with T2DM (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening * HbA1c ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol) as 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, SGLT-2i, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 antihyperglycaemia medications (metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone) according to local label ii. Hypertension iii. Dyslipidaemia 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 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 patient information. 6. In the investigator's opinion, patients are well-motivated, capable, and willing to: * Learn how to self-inject the Investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP) OR * Inject the IMP or accept injection from a designated person * Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise and exercise plan), maintain a diary, and complete required questionnaires, and handle the IMP as described in the instructions for use (IFU) Exclusion criteria: 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 gastrointestinal (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 (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) Glycaemia: For trial patients without T2DM: 5. History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening For trial patients with T2DM: 6. History of T1DM 7. 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, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and DPP-4i) 8. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial Further exclusion criteria apply.

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