Type 2 DiabetesPhase 3NCT07754461
A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
A Phase 3 study testing Survodutide in people with Type 2 Diabetes, run by Boehringer Ingelheim at 101 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Survodutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 101 sitesin 5 countries
- Study dates
- 24 Aug 2026to 1 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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:
- 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);
- 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);
- 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)
- Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
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- 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
- 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.
- 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)
Who cannot join
- Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
- 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
- History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
- Body weight change (self-reported) >5% within 90 days before screening (Visit 1)
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- 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).
- 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)
- Further exclusion criteria apply.
Trial locations and contacts
101 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
101 sites in 5 countries
United States71 sites, 21 recruiting
- Not yet recruiting
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Texas Diabetes and Endocrinology - Central Austin
Austin, Texas, 78731
- Suspended
Cahaba Research, Inc. - Trussville Location
Birmingham, Alabama, 35235
- Suspended
Elite Clinical Trials - Blackfoot
Blackfoot, Idaho, 83221
- Not yet recruiting
PanAmerican Clinical Research - Bluffton
Bluffton, South Carolina, 29910
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Ellipsis Research Group - Brooklyn
Brooklyn, New York, 11215
- Suspended
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520
- Not yet recruiting
Northern Pines Health Center - Buckley
Buckley, Michigan, 49620
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
San Fernando Valley Health
Canoga Park, California, 91304
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Diabetes & Endocrinology Associates of Stark County
Canton, Ohio, 44718
- Suspended
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411
- Suspended
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
- Suspended
Centricity Research, Endocrine Consultants
Columbus, Georgia, 31904
- Suspended
John Muir Physician Network Clinical Research Center
Concord, California, 94520
- Suspended
Privia Medical Group Gulf Coast, PLLC
Conroe, Texas, 77384
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8837
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Revival Research Institute, LLC - Dearborn
Dearborn, Michigan, 48126
- Suspended
Neighborhood Healthcare - Escondido
Escondido, California, 92025
- Suspended
Javara-Fayetteville-67354
Fayetteville, Georgia, 30214
- Suspended
Javara Inc. - Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304
- Suspended
Covenant Metabolic Specialists, LLC - Fort Myers
Fort Myers, Florida, 33912
- Suspended
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, 78626
- Not yet recruiting
Mission Research Institute - Gilbert
Gilbert, Arizona, 85296
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
PharmQuest Life Sciences
Greensboro, North Carolina, 27408
- Suspended
Encore Medical Research
Hollywood, Florida, 33024
- Not yet recruiting
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77084
- Not yet recruiting
Research Physicians Network
Houston, Texas, 77089
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Family First Clinical Research
Idaho Falls, Idaho, 83404
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Logan Health Research - Kalispell
Kalispell, Montana, 59901
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Accel Research Sites - Lakeland
Lakeland, Florida, 33803
- Suspended
Clinical Research of Central Florida - Lakeland
Lakeland, Florida, 33805
- Suspended
Tampa Bay Medical Research - Largo
Largo, Florida, 33777
- Not yet recruiting
Palm Research Center
Las Vegas, Nevada, 89128
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Balanced Life Health Care Solutions
Lawrenceville, Georgia, 30046
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
AMR Lexington
Lexington, Kentucky, 40509
- Suspended
Clinical Trials Research - Lincoln
Lincoln, California, 95648
- Suspended
Woodland International Research Group, Inc.
Little Rock, Arkansas, 72211
- Suspended
ARK Clinical Research
Long Beach, California, 90815
- Suspended
Advanced Medical Research - Maumee
Maumee, Ohio, 43537
- Not yet recruiting
LifeDoc Research, PLLC
Memphis, Tennessee, 38115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Solaris Clinical Research
Meridian, Idaho, 83646
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Southern Endocrinology Associates
Mesquite, Texas, 75149
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
New Horizon Research Center-Miami-69732
Miami, Florida, 33165
- Not yet recruiting
International Diabetes Center
Minneapolis, Minnesota, 55416
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Boeson Research - Missoula
Missoula, Montana, 59804
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Centricity Research - Morehead City
Morehead City, North Carolina, 28557
- Not yet recruiting
Tidewater Physicians Multispecialty Group
Newport News, Virginia, 23606
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Valley Clinical Trials, Inc.
Northridge, California, 91325
- Suspended
Tekton Research Oklahoma City
Oklahoma City, Oklahoma, 73134
- Suspended
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
- Suspended
Helios Clinical Research - Paradise Valley
Paradise Valley, Arizona, 85253
- Suspended
Helios Clinical Research - Phoenix
Phoenix, Arizona, 85028
- Suspended
Preferred Primary Care Physicians-Pittsburgh-63932
Pittsburgh, Pennsylvania, 15236
- Suspended
ERA Health Research - Redmond
Redmond, Washington, 98052
- Suspended
Covenant Metabolic Specialists, LLC - Brandon
Riverview, Florida, 33578
- Not yet recruiting
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Olympus Family Medicine
Salt Lake City, Utah, 84117
- Suspended
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78222
- Suspended
Pinnacle Clinical Research, LLC
San Antonio, Texas, 78229
- Not yet recruiting
Consano Clinical Research
Shavano Park, Texas, 78231
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Completed
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
- Suspended
Encompass Clinical Research, Spring Valley
Spring Valley, California, 91978
- Suspended
Arcturus Healthcare - Troy Internal Medicine Research Division
Troy, Michigan, 48098
- Not yet recruiting
Rophe Adult and Pediatric Medicine
Union City, Georgia, 30291
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Suspended
Preferred Primary Care Physicians - Matthew Drive
Uniontown, Pennsylvania, 15401
- Suspended
Covenant Metabolic Specialists, LLC - Sarasota
University Park, Florida, 34201
- Suspended
Diablo Clinical Research
Walnut Creek, California, 94598
- Suspended
Focus Clinical Research
West Hills, California, 91307
- Suspended
Encore Medical Research - Weston
Weston, Florida, 33331
- Suspended
Conquest Research
Winter Park, Florida, 32789
India13 sites, 13 recruiting
- Not yet recruiting
Gujarat Endocrine Centre
Ahmedabad, 380006
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
Ahmedabad, 380006
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
AIIMS Bhubaneshwar
Bhubaneswar, 751019
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
S.C.B. Medical College & Hospital
Cuttack, 753007
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Osmania Medical College & Hospital
Hyderabad, Afzalgunj, 500012
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Shree Mahalaxmi Diatone Institute
Kolhāpur, 416003
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, 226 014
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Diabetes Care and Research Centre
Nagpur, 440010
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Supe Heart & Diabetes Hospital & Research Centre
Nashik, 422002
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
AIIMS, New Delhi
New Delhi, 110029
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Jothydev's Diabetes Research Centre
Trivandrum, 695032
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
- Not yet recruiting
Vishakha Institute of Medical Sciences
Visakhapatnam, 530040
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Canada10 sites, 10 recruiting
- Recruiting
Centricity Research (Brampton)
Brampton, Ontario, L6S 0C6
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Centricity Research (Vaughan)
Concord, Ontario, L4K 4M2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Applied Medical Informatics Research Inc.
Montreal, Quebec, H4A 3T2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Endocrinologie Oasis Inc
Montreal, Quebec, H4J 1E3
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Centricity Research (Nepean)
Nepean, Ontario, K2J 0V2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Recherche Clinique Sigma Inc.
Québec, G1G 5X1
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Centricity Research (Bayview)
Toronto, Ontario, M4G 3E8
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Recruiting
Albion Finch Medical Centre
Toronto, Ontario, M9V 4B4
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Australia4 sites, 4 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Logan Hospital
Meadowbrook, Queensland, 4131
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Not yet recruiting
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Southern Adelaide Diabetes & Endocrine services
Oaklands Park, South Australia, 5046
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
New Zealand3 sites, 3 recruiting
- Recruiting
Waitemata Clinical Research
Auckland, 0626
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
- Recruiting
Momentum Clinical Research Dunedin
Central Dunedin, Dunedin, 9016
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
- Recruiting
Clinical Trials New Zealand Ltd
Hamilton, 3204
Boehringer Ingelheim, 0800440725, newzealand@bitrialsupport.com
About this study
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
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.
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo, Survodutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
SurvodutideDrug
Also called BI 456906
Survodutide
| Study group | Role | What they receive |
|---|---|---|
| Part A: Placebo | Placebo comparator | Placebo as an add-on to diet and exercise. Receives: Drug: Placebo |
| Part A: Low-dose survodutide | Experimental | Low-dose survodutide as an add-on to diet and exercise. Receives: Drug: Survodutide |
| Part A: High-dose survodutide | Experimental | High-dose survodutide as add-on to diet and exercise Receives: Drug: Survodutide |
| Part B: Placebo | Placebo comparator | Placebo as an add-on to anti-diabetic drugs. Receives: Drug: Placebo |
| Part B: Low-dose survodutide | Experimental | Low-dose survodutide as an add-on to anti-diabetic drugs. Receives: Drug: Survodutide |
| Part B: High-dose survodutide | Experimental | High-dose survodutide as an add-on to anti-diabetic drugs. Receives: Drug: Survodutide |
| Part C: Placebo | Placebo comparator | Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs. Receives: Drug: Placebo |
| Part C: Low-dose survodutide | Experimental | Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs. Receives: Drug: Survodutide |
| Part C: High-dose survodutide | Experimental | High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs. Receives: Drug: Survodutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Measured: At baseline and Week 41.
Secondary outcomes (11)
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Measured: At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Measured: At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Measured: At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Measured: At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Measured: At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Measured: At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Measured: At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
Measured: At baseline and Week 53.
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Measured: At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Measured: At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Measured: At baseline and Week 53.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start24 Aug 2026
- Primary completion17 Jan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754461
- Sponsor's protocol ID
- 1404-0115
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07754461
- Acronym / sponsor ID
- 1404-0115
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 17 Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo as an add-on to diet and exercise. |
| Part A: Low-dose survodutide | Experimental | Drug: SurvodutideLow-dose survodutide as an add-on to diet and exercise. |
| Part A: High-dose survodutide | Experimental | Drug: SurvodutideHigh-dose survodutide as add-on to diet and exercise |
| Part B: Placebo | Placebo comparator | Drug: PlaceboPlacebo as an add-on to anti-diabetic drugs. |
| Part B: Low-dose survodutide | Experimental | Drug: SurvodutideLow-dose survodutide as an add-on to anti-diabetic drugs. |
| Part B: High-dose survodutide | Experimental | Drug: SurvodutideHigh-dose survodutide as an add-on to anti-diabetic drugs. |
| Part C: Placebo | Placebo comparator | Drug: PlaceboPlacebo as an add-on to basal insulin therapy with or without anti-diabetic drugs. |
| Part C: Low-dose survodutide | Experimental | Drug: SurvodutideLow-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs. |
| Part C: High-dose survodutide | Experimental | Drug: SurvodutideHigh-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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:
- Body mass index (BMI) ≥23 kg/m2 at screening (Visit 1)
- 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
- 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.
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
- 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
- History of ketoacidosis or hyperosmolar state or coma within the last 6 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Hypoglycaemia unawareness or a history of severe hypoglycaemia within the last 3 months before screening (Visit 1) up to and including randomisation (Visit 2)
- Diabetic retinopathy or maculopathy currently under treatment, or that is reasonably anticipated to require such treatment over the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | Part A: Placebo, Part B: Placebo, Part C: Placebo |
| SurvodutideAlso: BI 456906Survodutide | Drug | Part A: High-dose survodutide, Part A: Low-dose survodutide, Part B: High-dose survodutide, Part B: Low-dose survodutide, Part C: High-dose survodutide, Part C: Low-dose survodutide |
Primary outcome
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Time frame: At baseline and Week 41.
11 secondary outcomes
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Time frame: At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Time frame: At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Time frame: At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Time frame: At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Time frame: At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Time frame: At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Time frame: At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Time frame: At baseline and Week 53.
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.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Time frame: At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Time frame: At baseline and Week 53.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
101 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Survodutide in people with Type 2 Diabetes, run by Boehringer Ingelheim at 101 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in United States, India, Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41 (time frame: At baseline and Week 41.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.