ObesityPhase 3SYNCHRONIZE™JPNCT06176365
A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
A Phase 3 study testing Survodutide in people with Obesity, run by Boehringer Ingelheim at 28 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- 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
- 274 participants
- Where
- 28 sitesJapan
- Study dates
- 16 Jan 2024to 3 Dec 2025
- 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)
- ≥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).
- 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
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- 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
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Signed and dated written informed consent in accordance with 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 patient information.
- 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)
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 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.
- 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:
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- For trial patients without T2DM:
- History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening
- For trial patients with T2DM:
- History of T1DM
- 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)
- New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial
- Further exclusion criteria apply.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Japan28 sites
Hosokawa Surgery Clinic
Aichi, Nagoya, 453-0812
Nagoya City University Hospital
Aichi, Nagoya, 467-8602
Chiba University Hospital
Chiba, Chiba, 260-8677
Gifu University Hospital
Gifu, Gifu, 501-1194
Jiyugaoka Yamada Clinic
Hokkaido, Obihiro, 080-0848
Yamasaki Family Clinic
Hyogo, Amagasaki, 660-0861
Kobe University Hospital
Hyogo, Kobe, 650-0017
Motomachi Takatsuka Naika Clinic
Kanagawa, Yokohama, 231-0023
Morinagaueno Clinic
Kumamoto, Kumamoto, 860-0863
Yoshimura Clinic
Kumamoto, Kumamoto, 861-8039
Medical Corporation KEISEIKAI Kajiyama Clinic
Kyoto, Kyoto, 600-8898
Ijinkai Takeda General Hospital
Kyoto, Kyoto, 601-1495
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
OCROM Clinic
Osaka, Suita, 565-0853
Saino Clinic
Saitama, Tokorozawa, 359-1141
Dojinkinenkai Meiwa Hospital
Tokyo, Chiyoda-ku, 101-0041
Suidoubashi Medical Clinic
Tokyo, Chiyoda-ku, 101-0065
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027
Tokyo Center Clinic
Tokyo, Chuo-ku, 103-0028
Fukuwa Clinic
Tokyo, Chuo-ku, 104-0031
Tokyo Asbo Clinic
Tokyo, Chuo-ku, 104-0031
New Medical Research System Clinic
Tokyo, Hachioji, 192-0046
Shimamura Kinen Hospital
Tokyo, Nerima-ku, 177-0051
Clinical Research Hospital Tokyo
Tokyo, Shinjuku-ku, 160-0004
HS Clinic
Tokyo, Shinjuku-ku, 169-0072
ToCROM Clinic
Tokyo, Shinjyuku-ku, 160-0008
Shinei Medical Healthcare Clinic
Tokyo, Suginami-ku, 166-0003
Ikebukuro Metropolitan Clinic
Tokyo, Toshima-ku, 171-0021
About this study
Official title: A Phase III, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of Survodutide Administered Subcutaneously Compared With Placebo in Patients With Obesity Disease in Japanese
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Survodutide, Placebo matching survodutide
- Medical subject headings
- Obesity
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 survodutideDrug
once weekly subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Survodutide - 3.6 mg | Experimental | Not described Receives: Drug: Survodutide |
| Survodutide - 6.0 mg | Experimental | Not described Receives: Drug: Survodutide |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo matching survodutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline to Week 76
Measured: at baseline, at week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Measured: at baseline, at week 76
Secondary outcomes (34)
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Measured: at baseline, at week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Measured: at baseline, at week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in body weight (kg)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in waist circumference measured at umbilical level (cm)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in waist circumference measured at midway between the lower rib margin and the iliac crest (cm)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour Patient reported outcome (PRO)
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.
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
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).
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
Measured: at baseline, at week 76
Relative change from baseline to Week 76 in liver fat content (%), assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in total fat mass (percentage [%]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in total fat mass (volume [L]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in lean body mass (percentage [%]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in lean body mass (volume [L]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in visceral fat mass (percentage [%]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in visceral fat mass (volume [L]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in contractile thigh muscle volume (percentage [%]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in contractile thigh muscle volume (volume [L]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in sub-cutaneous fat volume (volume [L]) assessed by MRI for body composition
Measured: at baseline, at week 76
Absolute change from baseline to Week 76 in sub-cutaneous fat volume (percentage [%]) assessed by MRI for body composition
Measured: at baseline, at week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start16 Jan 2024
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176365
- Sponsor's protocol ID
- 1404-0053
- Acronym
- SYNCHRONIZE™JP
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
Yokote K, Yamauchi T, Fukushima Y, Takatsuka Y, Kato M, Yan S, Inoue T, Borowska L, Brueckmann M, Ogawa W; SYNCHRONIZE-JP Trial Investigators. Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics of the Phase 3 SYNCHRONIZE-JP Trial. Diabetes Obes Metab. 2026 Aug;28(8):6595-6606. doi: 10.1111/dom.70862. Epub 2026 May 31.
PubMed 42219222
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of Survodutide Administered Subcutaneously Compared With Placebo in Patients With Obesity Disease in Japanese
- ClinicalTrials.gov ID
- NCT06176365
- Acronym / sponsor ID
- SYNCHRONIZE™JP / 1404-0053
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Survodutide - 3.6 mg | Experimental | Drug: Survodutide |
| Survodutide - 6.0 mg | Experimental | Drug: Survodutide |
| Placebo group | Placebo comparator | Drug: Placebo matching survodutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female, age ≥18 years at the time of signing informed consent
- Body Mass Index (BMI)
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Signed and dated written informed consent in accordance with 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 patient information.
Key exclusion criteria (13 listed)
- 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 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.
- 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)
- History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurvodutideAlso: BI 456906once weekly subcutaneous injection | Drug | Survodutide - 3.6 mg, Survodutide - 6.0 mg |
| Placebo matching survodutideonce weekly subcutaneous injection | Drug | Placebo group |
Primary outcome
Percentage change in body weight from baseline to Week 76
Time frame: at baseline, at week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Time frame: at baseline, at week 76
34 secondary outcomes
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Time frame: at baseline, at week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Time frame: at baseline, at week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in body weight (kg)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in waist circumference measured at umbilical level (cm)
Time frame: at baseline, at week 76
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
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Time frame: at baseline, at week 76
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
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
Time frame: at baseline, at week 76
Relative change from baseline to Week 76 in liver fat content (%), assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in total fat mass (percentage [%]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in total fat mass (volume [L]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in lean body mass (percentage [%]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in lean body mass (volume [L]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in visceral fat mass (percentage [%]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in visceral fat mass (volume [L]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in contractile thigh muscle volume (percentage [%]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in contractile thigh muscle volume (volume [L]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in sub-cutaneous fat volume (volume [L]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Absolute change from baseline to Week 76 in sub-cutaneous fat volume (percentage [%]) assessed by MRI for body composition
Time frame: at baseline, at week 76
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 42219222Yokote K, Yamauchi T, Fukushima Y, Takatsuka Y, Kato M, Yan S, Inoue T, Borowska L, Brueckmann M, Ogawa W; SYNCHRONIZE-JP Trial Investigators. Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics of the Phase 3 SYNCHRONIZE-JP Trial. Diabetes Obes Metab. 2026 Aug;28(8):6595-6606. doi: 10.1111/dom.70862. Epub 2026 May 31.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Survodutide in people with Obesity, run by Boehringer Ingelheim at 28 sites in Japan.
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 15 inclusion and 13 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 Japan. 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 76 (time frame: at baseline, at week 76). 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 NCT06176365, 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.