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A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (SYNCHRONIZE™-1)

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: NCT06066515
Recruitment Status : Active, not recruiting
First Posted : October 4, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:

This study is open to adults who are at least 18 years old and have

  • a body mass index (BMI) of 30 kg/m² or more, or
  • a BMI of 27 kg/m² or more and at least one health problem related to their weight.

People with type 2 diabetes cannot 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 overweight or obesity 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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity Without Type 2 Diabetes
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : December 19, 2025
Estimated Study Completion Date : January 16, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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 Drug: Placebo
once weekly subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change in body weight from baseline to Week 76 [ Time Frame: Baseline and at Week 76 ]
  2. Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76 [ Time Frame: Baseline and at Week 76 ]

Secondary Outcome Measures :
  1. Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76 [ Time Frame: Baseline and at Week 76 ]
  2. Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76 [ Time Frame: Baseline and at Week 76 ]
  3. Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76 [ Time Frame: Baseline and at Week 76 ]
  4. Absolute change from baseline to Week 76 in body weight (kg) [ Time Frame: Baseline and Week 76 ]
  5. Absolute change from baseline to Week 76 in waist circumference (cm) [ Time Frame: Baseline and at Week 76 ]
  6. Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg) [ Time Frame: Baseline and at Week 76 ]
  7. Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO) [ Time Frame: Baseline and at Week 76 ]
    "Capacity to Resist" domain score of the Eating Behaviour PRO is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.

  8. Absolute change from baseline to Week 76 in Eating Behaviour PRO total score [ Time Frame: Baseline and at Week 76 ]
    Eating Behaviour PRO total 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).

  9. Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2) [ Time Frame: Baseline and at Week 76 ]
  10. Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg) [ Time Frame: Baseline and at Week 76 ]
  11. Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%) [ Time Frame: Baseline and at Week 76 ]
  12. Absolute change from baseline to Week 76 in HbA1c (mmol/mol) [ Time Frame: Baseline and at Week 76 ]
  13. Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  14. Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L) [ Time Frame: Baseline and at Week 76 ]
  15. Absolute change from baseline to Week 76 in total cholesterol (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  16. Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  17. Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  18. Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  19. Absolute change from baseline to Week 76 in triglycerides (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  20. Absolute change from baseline to Week 76 in free fatty acids (mg/dL) [ Time Frame: Baseline and at Week 76 ]
  21. Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L) [ Time Frame: Baseline and at Week 76 ]
  22. Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L) [ Time Frame: Baseline and at Week 76 ]
  23. Absolute change from baseline to Week 76 in total fat volume (%) [ Time Frame: Baseline and at Week 76 ]
  24. Absolute change from baseline to Week 76 in total fat volume (L) [ Time Frame: Baseline and at Week 76 ]
  25. Absolute change from baseline to Week 76 in lean body volume (%) [ Time Frame: Baseline and at Week 76 ]
  26. Absolute change from baseline to Week 76 in lean body volume (L) [ Time Frame: Baseline and at Week 76 ]
  27. Absolute change from baseline to Week 76 in visceral fat volume (%) [ Time Frame: Baseline and at Week 76 ]
  28. Absolute change from baseline to Week 76 in visceral fat volume (L) [ Time Frame: Baseline and at Week 76 ]
  29. Absolute change from baseline to Week 76 in subcutaneous fat volume (%) [ Time Frame: Baseline and at Week 76. ]
  30. Absolute change from baseline to Week 76 in subcutaneous fat volume (L) [ Time Frame: Baseline and at Week 76. ]
  31. Relative change from baseline to Week 76 in liver fat content (%) [ Time Frame: Baseline and at Week 76 ]

Eligibility Criteria
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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, and at least the legal age of consent in countries where it is >18 years

  2. Body mass index (BMI) ≥30 kg/m^2 at screening, OR BMI ≥27 kg/m^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:

    • Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (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) ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high density lipoprotein (HDL) <40 mg/dL (<1.0 mmol/L) for men or HDL<50 mg/dL (<1.3 mmol/L) for women)
    • Obstructive sleep apnoea
    • Others.
  3. History of at least one self-reported unsuccessful dietary effort to lose body weight.

Further inclusion criteria apply.

Exclusion Criteria:

  1. Body weight change (self-reported) of >5% within 3 months before screening.
  2. Treatment with any medication for the indication obesity within 3 months before screening.
  3. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
  4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before screening.
  5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
  6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
  7. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening.
  8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Further exclusion criteria apply.

Contacts and Locations
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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): NCT06066515


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT06066515    
Other Study ID Numbers: 1404-0038
U1111-1288-9400 ( Registry Identifier: WHO registry )
2022-502529-17-00 ( Registry Identifier: CTIS )
First Posted: October 4, 2023    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 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: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight