DelfaGLP-1 Atlas

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SYNCHRONIZE™JP

CompletedPhase 3

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

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

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

28

Recruiting sites

—

Enrollment

274

actual

Study population

Obesity / overweight

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06176365
Org study ID1404-0053

Timeline

Milestones

Study first posted2023-12-19actual
Study start2024-01-16actual
Primary completion2025-12-03actual
Study completion2025-12-03actual
Last update posted2026-04-30actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (36)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
19
Cardiometabolic biomarkers
8
Glycemic / diabetes
4
MASH / liver
3
Patient-reported / QoL
2

Weight & body composition

19 endpoints
Primary/protocol endpoint

Percentage change in body weight from baseline to Week 76

Time frame:at baseline, at week 76

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

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

Time frame:at baseline, at week 76

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

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

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

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

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

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

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

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

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

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

Subcutaneous fat, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

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

Time frame:at baseline, at week 76

change from baseline, improvement

MASH / liver

3 endpoints
Secondary/protocol endpoint

Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)

Time frame:at baseline, at week 76

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)

Time frame:at baseline, at week 76

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

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

Liver fat content, change

percent change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in free fatty acids (mg/dL)

Time frame:at baseline, at week 76

Free fatty acids, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at baseline, at week 76

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.