Back to resultsA Study to Test Whether BI 456906 Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (SYNCHRONIZE™-1)
Primary Purpose
Obesity
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BI 456906
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: 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 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 Dyslipidaemia Obstructive sleep apnoea Others. History of at least one self-reported unsuccessful dietary effort to lose body weight. Further inclusion criteria apply. Exclusion Criteria: Body weight change (self-reported) of >5% within 3 months before screening. Treatment with any medication for the indication obesity within 3 months before screening. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening. 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. Heart failure (HF) with New York Heart Association (NYHA) functional class IV. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction). 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. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). Further exclusion criteria apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BI 456906 3.6 mg
BI 456906 6.0 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage change in body weight from baseline to Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Secondary Outcome Measures
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Absolute change from baseline to Week 76 in body weight (kg)
Absolute change from baseline to Week 76 in waist circumference (cm)
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)
"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.
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
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).
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
Absolute change from baseline to Week 76 in total fat mass (%)
Absolute change from baseline to Week 76 in total fat mass (kg)
Absolute change from baseline to Week 76 in lean body mass (%)
Absolute change from baseline to Week 76 in lean body mass (kg)
Absolute change from baseline to Week 76 in visceral fat mass (%)
Absolute change from baseline to Week 76 in visceral fat mass (kg)
Relative change from baseline to Week 76 in liver fat content (%)
Full Information
NCT ID
NCT06066515
First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT06066515
Brief Title
A Study to Test Whether BI 456906 Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Acronym
SYNCHRONIZE™-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 16, 2023 (Anticipated)
Primary Completion Date
December 19, 2025 (Anticipated)
Study Completion Date
January 16, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BI 456906 3.6 mg
Arm Type
Experimental
Arm Title
BI 456906 6.0 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 456906
Other Intervention Name(s)
survodutide
Intervention Description
once weekly subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once weekly subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage change in body weight from baseline to Week 76
Time Frame
Baseline and at Week 76
Title
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Time Frame
Baseline and at Week 76
Secondary Outcome Measure Information:
Title
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Time Frame
Baseline and at Week 76
Title
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Time Frame
Baseline and at Week 76
Title
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in body weight (kg)
Time Frame
Baseline and Week 76
Title
Absolute change from baseline to Week 76 in waist circumference (cm)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)
Description
"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.
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Description
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).
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in triglycerides (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in total fat mass (%)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in total fat mass (kg)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in lean body mass (%)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in lean body mass (kg)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in visceral fat mass (%)
Time Frame
Baseline and at Week 76
Title
Absolute change from baseline to Week 76 in visceral fat mass (kg)
Time Frame
Baseline and at Week 76
Title
Relative change from baseline to Week 76 in liver fat content (%)
Time Frame
Baseline and at Week 76
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Dyslipidaemia
Obstructive sleep apnoea
Others.
History of at least one self-reported unsuccessful dietary effort to lose body weight.
Further inclusion criteria apply.
Exclusion Criteria:
Body weight change (self-reported) of >5% within 3 months before screening.
Treatment with any medication for the indication obesity within 3 months before screening.
Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
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.
Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
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.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Further exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info
Learn more about this trial
A Study to Test Whether BI 456906 Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
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