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Phase 3RecruitingInterventionalNCT07754461

A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

A Phase III, Randomised, Double-blind, Parallel-group, 56-week Study, Evaluating the Efficacy and Safety of Survodutide (BI 456906), Compared With Placebo, in Participants With Type 2 Diabetes, as an Adjunct to Diet and Physical Activity Alone or in Combination With Either Oral Antidiabetic Medications or Insulin

  • Type 2 Diabetes
I want to take partRefer a patient13 sites in India · 121 worldwide

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Boehringer Ingelheim
Enrolment target
600
Started
24 August 2026
Main results due (estimated)
17 January 2028
Study ends (estimated)
1 May 2028
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Quadruple (participant, care provider, investigator, outcomes assessor)
Sites
121 · 13 in India
First posted
10 August 2026
Registry updated
30 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full eligibility 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. Diagnosed with type 2 diabetes mellitus (T2D) (e.g. American diabetes association (ADA)/European association for the study of diabetes (EASD) guidelines) and must meet requirements for one of background therapy parts A, B or C:

   1. Part A: Naïve to insulin therapy and have not used oral or injectable anti-hyperglycaemic (diabetes) medication for at least 90 days prior to screening (Visit 1) and glycosylated haemoglobin A1c (HbA1c) ≥7.0 (≥53 mmol/mol) and \<9.5% (\<80 mmol/mol) as measured by the central laboratory at screening (Visit 1);
   2. Part B: Treated with stable dose of oral antidiabetic medication (OAD) for 90 days prior to screening (Visit 1) as monotherapy or combination of: Maximum tolerated dose of metformin and/or Maximum tolerated dose of sulfonylurea and/or Maximum tolerated dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and HbA1c ≥7.0% (≥53 mmol/mol) and \<10.5% (\<91 mmol/mol) as measured by the central laboratory at screening (Visit 1);
   3. Part C: Stable use of basal insulin at a dose of ≥20 international units (IU)/day with or without stable dose of metformin and/or SGLT2i for 90 days prior to screening (Visit 1) and HbA1c ≥7.0% (≥53 mmol/mol) and \<10.5% (\<91 mmol/mol) as measured by the central laboratory at screening (Visit 1)
3. Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
5. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per international council for harmonisation of technical requirements for pharmaceuticals for human use M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP); Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a diary, complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)

Exclusion criteria:

1. Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
2. Treatment within 90 days before screening (Visit 1) up to and including randomisation (Visit 2) with any: glucagon-like peptide-1 receptor (GLP-1R) agonists including GLP-1R agonist/glucose-dependent insulinotropic polypeptide (GIP) combinations, amylin or incretin combinations; Glucose-lowering drugs other than stated in the inclusion criteria for each part (i.e. metformin, Sodium-Glucose Cotransporter 2 Inhibitor (SGLT2i), basal insulin, depending on the background therapy part); Glucose-lowering investigational drug; Any anti-obesity medication including bupropion/naltrexone, orlistat, phentermine, and phentermine/topiramate
3. History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
4. Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
5. Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
6. Body weight change (self-reported) \>5% within 90 days before screening (Visit 1)
7. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, including any prior bariatric surgery. The following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening (Visit 1), (2) lap banding, if the band has been removed \>1 year before screening (Visit 1), (3) intragastric balloon, if the balloon has been removed \>1 year before screening (Visit 1), (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening (Visit 1).
8. Answered "yes" to any of the suicide-related behaviours (Actual attempt, Interrupted attempt, Aborted attempt, Preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening (Visit 1) up to and including randomisation (Visit 2)
9. Further exclusion criteria apply.

What this study is about

In the sponsor’s own words, from the registry.

This study aims to find out whether a study medicine called survodutide helps people control their blood sugar. Adults who live with type 2 diabetes and with a body mass index (BMI) of 23 kg/m2 or higher can join.

The study has 3 parts. In each part the study compares survodutide with placebo. Survodutide is being developed to treat several health problems including type 2 diabetes. Placebo looks like survodutide but does not contain any medicine.

Depending on a person's diabetes treatment, a person will be assigned either to

* Part A: healthy eating and physical activity * Part B: diabetes tablets (no injection of insulin) * Part C: injection of insulin (with or without diabetes tablets)

Participants are randomly put into 1 of 3 groups, which means the group is chosen by chance. Two groups of participants get survodutide at different dose levels, and the third group gets placebo as injection under the skin once a week. You have a 2 in 3 chance of getting survodutide. During the study, participants continue their regular diabetes treatment.

Participants are in the study for about 1 year and 2 months. During this time, they attend up to 12 visits at the site and receive at least 9 phone calls. Study doctors regularly test participants' blood sugar by checking their HbA1c values and other laboratory test results. The study doctor also regularly checks participants' health and takes note of any changes. For each study part, the results will be compared between the survodutide and the placebo group to see whether the treatment works.

What participants receive

  • Placebo comparator

    Part A: Placebo

    Placebo as an add-on to diet and exercise.

    Drug: Placebo

  • Experimental

    Part A: Low-dose survodutide

    Low-dose survodutide as an add-on to diet and exercise.

    Drug: Survodutide

  • Experimental

    Part A: High-dose survodutide

    High-dose survodutide as add-on to diet and exercise

    Drug: Survodutide

  • Placebo comparator

    Part B: Placebo

    Placebo as an add-on to anti-diabetic drugs.

    Drug: Placebo

  • Experimental

    Part B: Low-dose survodutide

    Low-dose survodutide as an add-on to anti-diabetic drugs.

    Drug: Survodutide

  • Experimental

    Part B: High-dose survodutide

    High-dose survodutide as an add-on to anti-diabetic drugs.

    Drug: Survodutide

  • Placebo comparator

    Part C: Placebo

    Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.

    Drug: Placebo

  • Experimental

    Part C: Low-dose survodutide

    Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.

    Drug: Survodutide

  • Experimental

    Part C: High-dose survodutide

    High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.

    Drug: Survodutide

Interventions

  • PlaceboDrug

  • SurvodutideDrug

    Also known as BI 456906

What the study measures

Primary outcomes

  1. Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41

    Time frame: At baseline and Week 41.

Secondary outcomes

  1. Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53

    Time frame: At baseline and Week 53.

  2. Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41

    Time frame: At baseline and Week 41.

  3. Achievement of HbA1c <5.7% (yes/no) at Week 41

    Time frame: At Week 41.

  4. Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53

    Time frame: At baseline and Week 53.

  5. Percent change in body weight (kg) from baseline to Week 53

    Time frame: At baseline and Week 53.

  6. Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53

    Time frame: At baseline and Week 53.

  7. Relative change in triglycerides from baseline to Week 53

    Time frame: At baseline and Week 53.

  8. Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53

    CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation

    Time frame: At baseline and Week 53.

  9. Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable

    Time frame: At baseline and Week 53.

  10. Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53

    Time frame: At baseline and Week 53.

  11. Part C: Absolute change in daily basal insulin dose from baseline to Week 53

    Time frame: At baseline and Week 53.

Who is running it

Lead sponsor
Boehringer Ingelheim
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Boehringer Ingelheim
Data monitoring committee
Yes
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
1404-0115

Study sites(121)

Showing 40 of 121 sites, filter to narrow it down. 57 of 121 on this study are recruiting right now, and 13 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
Yes
When
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access
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.

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Source: ClinicalTrials.gov record NCT07754461, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar | Trialion