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A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease (SYNCHRONIZE™JP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06176365
Recruitment Status : Active, not recruiting
First Posted : December 19, 2023
Last Update Posted : June 12, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Survodutide Drug: Placebo matching survodutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2023
Estimated Primary Completion Date : February 2, 2026
Estimated Study Completion Date : February 2, 2026

Arm Intervention/treatment
Experimental: Survodutide - 3.6 mg Drug: Survodutide
once weekly subcutaneous injection
Other Name: BI 456906

Experimental: Survodutide - 6.0 mg Drug: Survodutide
once weekly subcutaneous injection
Other Name: BI 456906

Placebo Comparator: Placebo group Drug: Placebo matching survodutide
once weekly subcutaneous injection




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

    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 ]

    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 ]
  21. Absolute change from baseline to Week 76 in free fatty acids (mg/dL) [ Time Frame: at baseline, at week 76 ]
  22. Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L) [ Time Frame: at baseline, at week 76 ]
  23. Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L) [ Time Frame: at baseline, at week 76 ]
  24. 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 ]
  25. 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 ]
  26. 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 ]
  27. 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 ]
  28. 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 ]
  29. 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 ]
  30. 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 ]
  31. Absolute change from baseline to Week 76 in skeletal muscle mass (percentage [%]) assessed by MRI for body composition [ Time Frame: at baseline, at week 76 ]
  32. Absolute change from baseline to Week 76 in skeletal muscle mass (volume [L]) assessed by MRI for body composition [ Time Frame: at baseline, at week 76 ]
  33. Absolute change from baseline to Week 76 in sub-cutaneous fat mass (volume [L]) assessed by MRI for body composition [ Time Frame: at baseline, at week 76 ]
  34. Absolute change from baseline to Week 76 in sub-cutaneous fat mass (percentage [%]) assessed by MRI for body composition [ Time Frame: at baseline, at week 76 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06176365


Locations
Show Show 28 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT06176365    
Other Study ID Numbers: 1404-0053
First Posted: December 19, 2023    Key Record Dates
Last Update Posted: June 12, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight