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Trial · Interventional

CompletedPhase 3Registry data

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

Short name SYNCHRONIZE™-2

NCTNCT06066528 (opens ClinicalTrials.gov in a new tab)Other id1404-0041Other id2022-502531-18-00Other idU1111-1289-0247
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
755 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Quadruple masking
Countries
19 countries

United States, Australia, Belgium, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Hungary, Japan, Netherlands, New Zealand, Poland, South Korea, Spain, Sweden, United Kingdom

Start
27 Nov 2023
Primary completion
12 Dec 2025
Completion
1 Apr 2026
First posted
4 Oct 2023
Last update posted
6 Aug 2026
Conditions
Obesity · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024202520262027
  1. Ph 3

    SYNCHRONIZE™-2

    NCT06066528

    27 Nov 2023 to 1 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SurvodutideCombination product
  • PlaceboCombination product

Arms3

  • Experimental

    Survodutide 3.6 mg

  • Experimental

    Survodutide 6.0 mg

  • Placebo comparator

    Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(20)

  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

    Registry 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.

  9. Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score

    Time frame · Baseline and at Week 76

    Registry 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).

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

Baseline characteristics in the SYNCHRONIZE™-2 randomized phase 3 trial of survodutide, a glucagon receptor/GLP-1 receptor dual agonist, for obesity in people with type 2 diabetes.

Wharton et al. 2026Diabetes, obesity & metabolismcited by 5

PMID 41216778PMC12803687DOI 10.1111/dom.70263PUB-41216778

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2026

8 results

Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes.

Wharton et al. 2026The New England journal of medicine

PMID 42820639DOI 10.1056/nejmoa2607219PUB-42820639

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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) ≥27 kg/m\^2 at screening. 3. 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. 4. HbA1c ≥6.5% (≥48 mmol/mol) and \<10% (\<86 mmol/mol) as measured by the central laboratory at screening. 5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines. 6. 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. 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). 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). 5. 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. 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). Further exclusion criteria apply.

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