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)

Boehringer Ingelheim

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: survodutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06066515

1404-0038

U1111-1288-9400 (Registry Identifier)

2022-502529-17-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 725 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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725 participants in 3 patient groups, including a placebo group

Survodutide 3.6 mg

Experimental group

Treatment:

Drug: survodutide

Survodutide 6.0 mg

Experimental group

Treatment:

Drug: survodutide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo