Clinical trial Recruiting at 15 sites Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorBoehringer Ingelheim
Industry-sponsored
Locations101 sites (Birmingham, Alabama and 100 other locations)
StatusRecruiting
StartedAugust 24, 2026
Main results expectedJanuary 17, 2028
Study endsMay 1, 2028
Registry record updatedOctober 29, 2026
Trial IDNCT07754461 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.