See if survodutide helps people with type 2 diabetes control blood sugar
Official title: 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
Run by Boehringer Ingelheim · NCT07754461 · Data updated 2026-11-12
This study tests survodutide versus placebo to see if it helps adults with type 2 diabetes manage their blood sugar.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Locations | 101 sites (Birmingham, Alabama and 100 other locations) |
| Status | Recruiting |
| Started | August 24, 2026 |
| Main results expected | January 17, 2028 |
| Study ends | May 1, 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07754461 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with type 2 diabetes and BMI ≥23, who are in one of three treatment strata (lifestyle modification, oral meds, or insulin therapy) and meet specific HbA1c criteria.
✕Probably not a fit
Some participants may not experience blood sugar improvement or may experience adverse effects and receive placebo.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 trial looks at survodutide for adults with type 2 diabetes and BMI of 23 or higher. Participants are randomly assigned to one of three groups: survodutide at two different doses or placebo, with weekly injections under the skin. The study has three parts driven by baseline treatment: lifestyle changes (Part A), oral diabetes medications (Part B), or insulin therapy (Part C). Each part compares survodutide to placebo, and participation progresses based on treatment stratum. Recruitment occurs at multiple sites in the United States with Boehringer Ingelheim as lead sponsor.
Why it matters
Potential benefit: If successful, participants taking survodutide could see better blood sugar control compared with placebo.
How similar studies have gone: Previous studies of similar GLP-1–based therapies in type 2 diabetes have shown meaningful improvements in glycemic control, though this exact regimen is being tested in a large Phase 3 trial.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia Recruiting -
Southern Adelaide Diabetes & Endocrine services
Oaklands Park, South Australia, Australia Recruiting -
Fraser Clinical Trials
New Westminster, British Columbia, Canada Recruiting -
Centricity Research (Brampton)
Brampton, Ontario, Canada Recruiting -
Centricity Research (Vaughan)
Concord, Ontario, Canada Recruiting -
Centricity Research (Nepean)
Nepean, Ontario, Canada Recruiting
Show 44 more locations
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Centricity Research (Bayview)
Toronto, Ontario, Canada Recruiting -
Diabetes Heart Research Centre
Toronto, Ontario, Canada Recruiting -
Albion Finch Medical Centre
Toronto, Ontario, Canada Recruiting -
Applied Medical Informatics Research Inc.
Montreal, Quebec, Canada Recruiting -
Endocrinologie Oasis Inc
Montreal, Quebec, Canada Recruiting -
Recherche Clinique Sigma Inc.
Québec, Canada Recruiting -
Momentum Clinical Research Dunedin
Central Dunedin, Dunedin, New Zealand Recruiting -
Waitemata Clinical Research
Auckland, New Zealand Recruiting -
Clinical Trials New Zealand Ltd
Hamilton, New Zealand Recruiting -
Cahaba Research, Inc. - Trussville Location
Birmingham, Alabama, United States Suspended -
Mission Research Institute - Gilbert
Gilbert, Arizona, United States Not yet recruiting -
Helios Clinical Research - Paradise Valley
Paradise Valley, Arizona, United States Suspended -
Helios Clinical Research - Phoenix
Phoenix, Arizona, United States Suspended -
Woodland International Research Group, Inc.
Little Rock, Arkansas, United States Suspended -
San Fernando Valley Health
Canoga Park, California, United States Not yet recruiting -
John Muir Physician Network Clinical Research Center
Concord, California, United States Suspended -
Neighborhood Healthcare - Escondido
Escondido, California, United States Suspended -
Clinical Trials Research - Lincoln
Lincoln, California, United States Suspended -
ARK Clinical Research
Long Beach, California, United States Suspended -
Valley Clinical Trials, Inc.
Northridge, California, United States Suspended -
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States Suspended -
Diablo Clinical Research
Walnut Creek, California, United States Suspended -
Focus Clinical Research
West Hills, California, United States Suspended -
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States Suspended -
Covenant Metabolic Specialists, LLC - Fort Myers
Fort Myers, Florida, United States Suspended -
Encore Medical Research
Hollywood, Florida, United States Suspended -
Accel Research Sites - Lakeland
Lakeland, Florida, United States Suspended -
Clinical Research of Central Florida - Lakeland
Lakeland, Florida, United States Suspended -
Tampa Bay Medical Research - Largo
Largo, Florida, United States Suspended -
New Horizon Research Center-Miami-69732
Miami, Florida, United States Suspended -
Covenant Metabolic Specialists, LLC - Brandon
Riverview, Florida, United States Suspended -
Covenant Metabolic Specialists, LLC - Sarasota
University Park, Florida, United States Suspended -
Encore Medical Research - Weston
Weston, Florida, United States Suspended -
Conquest Research
Winter Park, Florida, United States Suspended -
Centricity Research, Endocrine Consultants
Columbus, Georgia, United States Suspended -
Javara-Fayetteville-67354
Fayetteville, Georgia, United States Suspended -
Balanced Life Health Care Solutions
Lawrenceville, Georgia, United States Not yet recruiting -
Rophe Adult and Pediatric Medicine
Union City, Georgia, United States Not yet recruiting -
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States Not yet recruiting -
Elite Clinical Trials - Blackfoot
Blackfoot, Idaho, United States Suspended -
Family First Clinical Research
Idaho Falls, Idaho, United States Not yet recruiting -
Solaris Clinical Research
Meridian, Idaho, United States Not yet recruiting -
AMR Lexington
Lexington, Kentucky, United States Suspended -
Endocrine and Metabolic Consultants
Rockville, Maryland, United States Not yet recruiting
+51 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.