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Completed

NCT Number: NCT06066528

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. 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 who also have diabetes 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 study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nepean Hospital, Kingswood, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) ≥27 kg/m^2 at screening.
  • Diagnosed with Type 2 diabetes mellitus (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 for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
  • 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.
  • Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor [DPP-4il).
  • 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.

Treatment and study plan

Survodutide

Combination Product

once weekly subcutaneous injection, pre-filled syringe

Other names: BI 456906

Placebo

Combination Product

once weekly subcutaneous injection, pre-filled syringe

Primary outcomes

  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 outcomes

  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 at Week 76

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

    Time frame: Baseline and at Week 76

  6. Absolute change from baseline to Week 76 in waist circumference (cm)

    Time frame: Baseline and at Week 76

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

    Time frame: Baseline and at Week 76

  8. Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of 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.

  9. Key secondary endpoint: 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).

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

    Time frame: Baseline and at Week 76

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

    Time frame: Baseline and at Week 76

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

    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) cholesterol (mg/dL)

    Time frame: Baseline and at Week 76

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

    Time frame: Baseline and at Week 76

  18. Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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 and Type 2 Diabetes Mellitus

Acronym: SYNCHRONIZE™-2

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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