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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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 is being tested

Sponsor: Boehringer Ingelheim · Participants: 600 · Started: Aug 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07754461

Locations in the U.S.

AlabamaCahaba Research, Inc. - Trussville Location, Birmingham (Not yet recruiting)
ArizonaMission Research Institute - Gilbert, Gilbert (Not yet recruiting)
Helios Clinical Research - Paradise Valley, Paradise Valley (Not yet recruiting)
Arizona Liver Health - Peoria 85381, Peoria (Not yet recruiting)
Helios Clinical Research - Phoenix, Phoenix (Not yet recruiting)
ArkansasWoodland International Research Group, Inc., Little Rock
CaliforniaSan Fernando Valley Health, Canoga Park (Not yet recruiting)
John Muir Physician Network Clinical Research Center, Concord
Neighborhood Healthcare - Escondido, Escondido (Not yet recruiting)
Clinical Trials Research - Lincoln, Lincoln (Not yet recruiting)
ARK Clinical Research, Long Beach
Infinity Clinical Research, Norco (Not yet recruiting)
Valley Clinical Trials, Inc., Northridge
Fomat Medical Research, Oxnard (Not yet recruiting)
Encompass Clinical Research, Spring Valley, Spring Valley
University Clinical Investigators, Inc., Tustin (Not yet recruiting)
Diablo Clinical Research, Walnut Creek
Focus Clinical Research, West Hills
FloridaClinical Research of West Florida, Inc., Clearwater
Northeast Research Institute, Fleming Island (Not yet recruiting)
Covenant Metabolic Specialists, LLC - Fort Myers, Fort Myers
Encore Medical Research, Hollywood
Northeast Research Institute, Jacksonville (Not yet recruiting)
Accel Research Sites - Lakeland, Lakeland (Not yet recruiting)
Clinical Research of Central Florida - Lakeland, Lakeland (Not yet recruiting)
Tampa Bay Medical Research - Largo, Largo
New Horizon Research Center-Miami-69732, Miami (Not yet recruiting)
South Broward Research, Miramar (Not yet recruiting)
Covenant Metabolic Specialists, LLC - Brandon, Riverview
Covenant Metabolic Specialists, LLC - Sarasota, University Park
Metabolic Research Institute, Inc., West Palm Beach (Not yet recruiting)
Encore Medical Research - Weston, Weston
Conquest Research, Winter Park
GeorgiaCentricity Research, Endocrine Consultants, Columbus
Javara-Fayetteville-67354, Fayetteville
Balanced Life Health Care Solutions, Lawrenceville (Not yet recruiting)
Rophe Adult and Pediatric Medicine, Union City (Not yet recruiting)
HawaiiPacific Diabetes & Endocrine Center, Honolulu (Not yet recruiting)
IdahoElite Clinical Trials - Blackfoot, Blackfoot (Not yet recruiting)
Family First Clinical Research, Idaho Falls (Not yet recruiting)
Solaris Clinical Research, Meridian (Not yet recruiting)
IllinoisEvanston Premier Healthcare Research LLC, Skokie (Not yet recruiting)
KansasCotton O'Neil Mulvane, Topeka (Not yet recruiting)
KentuckyAMR Lexington, Lexington (Not yet recruiting)
MarylandEndocrine and Metabolic Consultants, Rockville (Not yet recruiting)
MichiganNorthern Pines Health Center - Buckley, Buckley (Not yet recruiting)
Revival Research Institute, LLC - Dearborn, Dearborn
Arcturus Healthcare - Troy Internal Medicine Research Division, Troy (Not yet recruiting)
MinnesotaInternational Diabetes Center, Minneapolis (Not yet recruiting)
MississippiOlive Branch Family Medical Center, Olive Branch (Not yet recruiting)
SKY Clinical Research Network Group - Ridgeland, Ridgeland (Not yet recruiting)
MissouriStudyMetrix Research, LLC, City of Saint Peters (Not yet recruiting)
MontanaLogan Health Research - Kalispell, Kalispell (Not yet recruiting)
Boeson Research - Missoula, Missoula (Not yet recruiting)
NevadaPalm Research Center, Las Vegas (Not yet recruiting)
New MexicoAlbuquerque Clinical Trials, Albuquerque (Not yet recruiting)
New YorkEllipsis Research Group - Brooklyn, Brooklyn (Not yet recruiting)
North CarolinaJavara Inc. - Cape Fear Valley Medical Center, Fayetteville (Not yet recruiting)
PharmQuest Life Sciences, Greensboro (Not yet recruiting)
Centricity Research - Morehead City, Morehead City
OhioDiabetes & Endocrinology Associates of Stark County, Canton (Not yet recruiting)
Advanced Medical Research - Maumee, Maumee (Not yet recruiting)
New Venture Medical Research, Wadsworth (Not yet recruiting)
OklahomaTekton Research Oklahoma City, Oklahoma City
PennsylvaniaHeritage Valley Medical Group, Beaver (Not yet recruiting)
Preferred Primary Care Physicians, Pittsburgh (Not yet recruiting)
Preferred Primary Care Physicians-Pittsburgh-63932, Pittsburgh (Not yet recruiting)
Preferred Primary Care Physicians - Matthew Drive, Uniontown (Not yet recruiting)
South CarolinaPanAmerican Clinical Research - Bluffton, Bluffton (Not yet recruiting)
Spartanburg Medical Research, Spartanburg (Not yet recruiting)
TennesseeUniversity Diabetes & Endocrine Consultants, Chattanooga
LifeDoc Research, PLLC, Memphis (Not yet recruiting)
TexasTexas Diabetes and Endocrinology - Central Austin, Austin
South Texas Research Institute - Brownsville, Brownsville (Not yet recruiting)
Privia Medical Group Gulf Coast, PLLC, Conroe
University of Texas Southwestern Medical Center, Dallas (Not yet recruiting)
Pinnacle Clinical Research - Georgetown, Georgetown
Biopharma Informatic, Inc. Research Center, Houston (Not yet recruiting)
Juno Research, LLC, Houston (Not yet recruiting)
Research Physicians Network, Houston (Not yet recruiting)
Southern Endocrinology Associates, Mesquite (Not yet recruiting)
Pinnacle Clinical Research - San Antonio, San Antonio
Pinnacle Clinical Research, LLC, San Antonio (Not yet recruiting)
Consano Clinical Research, Shavano Park (Not yet recruiting)
Texas Valley Clinical Research, Weslaco (Not yet recruiting)
UtahOlympus Family Medicine, Salt Lake City
VirginiaTidewater Physicians Multispecialty Group, Newport News (Not yet recruiting)
WashingtonERA Health Research - Redmond, Redmond
WisconsinClinical Investigation Specialists, Inc.-Kenosha-69111, Kenosha (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.