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Can a weekly shot tame blood sugar in type 2 diabetes?

NCT ID NCT07754461

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Aug 10, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This phase 3 trial asks whether survodutide, an investigational weekly injection, can help adults with type 2 diabetes lower their blood sugar more than a placebo. Around 600 participants, who also follow diet and exercise or take standard diabetes medications (including insulin), will be randomly assigned to one of two survodutide doses or placebo for about a year. The study tracks changes in HbA1c, a key blood sugar marker, to see if the treatment is effective and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: survodutide (BI 456906), an investigational injectable medicine
What this could lead to: If it works, survodutide could offer a new weekly injection option to help people with type 2 diabetes better control their blood sugar.
What could go wrong: This is an early-phase test in a large group; survodutide may not prove more effective than placebo, and side effects are possible. Results will take time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

121 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AIIMS Bhubaneshwar
NOT_YET_RECRUITING

Bhubaneswar, 751019, India
AIIMS, New Delhi
NOT_YET_RECRUITING

New Delhi, 110029, India
AMR Lexington
NOT_YET_RECRUITING

Lexington, Kentucky, 40509, United States
ARK Clinical Research
RECRUITING

Long Beach, California, 90815, United States
Accel Research Sites - Lakeland
NOT_YET_RECRUITING

Lakeland, Florida, 33803, United States
Advanced Medical Research - Maumee
NOT_YET_RECRUITING

Maumee, Ohio, 43537, United States
Albion Finch Medical Centre
NOT_YET_RECRUITING

Toronto, Ontario, M9V 4B4, Canada
Albuquerque Clinical Trials
NOT_YET_RECRUITING

Albuquerque, New Mexico, 87102, United States
Applied Medical Informatics Research Inc.
NOT_YET_RECRUITING

Montreal, Quebec, H4A 3T2, Canada
Arcturus Healthcare - Troy Internal Medicine Research Division
NOT_YET_RECRUITING

Troy, Michigan, 48098, United States
Arizona Liver Health - Peoria 85381
NOT_YET_RECRUITING

Peoria, Arizona, 85381, United States
Baker Heart and Diabetes Institute
NOT_YET_RECRUITING

Melbourne, Victoria, 3004, Australia
Balanced Life Health Care Solutions
NOT_YET_RECRUITING

Lawrenceville, Georgia, 30046, United States
Biopharma Informatic, Inc. Research Center
NOT_YET_RECRUITING

Houston, Texas, 77084, United States
Boeson Research - Missoula
NOT_YET_RECRUITING

Missoula, Montana, 59804, United States
Cahaba Research, Inc. - Trussville Location
NOT_YET_RECRUITING

Birmingham, Alabama, 35235, United States
Centricity Research (Bayview)
NOT_YET_RECRUITING

Toronto, Ontario, M4G 3E8, Canada
Centricity Research (Brampton)
RECRUITING

Brampton, Ontario, L6S 0C6, Canada
Centricity Research (Nepean)
NOT_YET_RECRUITING

Nepean, Ontario, K2J 0V2, Canada
Centricity Research (Vaughan)
NOT_YET_RECRUITING

Concord, Ontario, L4K 4M2, Canada
Centricity Research - Morehead City
RECRUITING

Morehead City, North Carolina, 28557, United States
Centricity Research, Endocrine Consultants
RECRUITING

Columbus, Georgia, 31904, United States
Clinical Investigation Specialists, Inc.-Kenosha-69111
NOT_YET_RECRUITING

Kenosha, Wisconsin, 53144, United States
Clinical Research of Central Florida - Lakeland
NOT_YET_RECRUITING

Lakeland, Florida, 33805, United States
Clinical Research of West Florida, Inc.
RECRUITING

Clearwater, Florida, 33765, United States
Clinical Trials New Zealand Ltd
NOT_YET_RECRUITING

Hamilton, 3204, New Zealand
Clinical Trials Research - Lincoln
NOT_YET_RECRUITING

Lincoln, California, 95648, United States
Conquest Research
RECRUITING

Winter Park, Florida, 32789, United States
Consano Clinical Research
NOT_YET_RECRUITING

Shavano Park, Texas, 78231, United States
Cotton O'Neil Mulvane
NOT_YET_RECRUITING

Topeka, Kansas, 66606, United States
Covenant Metabolic Specialists, LLC - Brandon
RECRUITING

Riverview, Florida, 33578, United States
Covenant Metabolic Specialists, LLC - Fort Myers
RECRUITING

Fort Myers, Florida, 33912, United States
Covenant Metabolic Specialists, LLC - Sarasota
RECRUITING

University Park, Florida, 34201, United States
Deenanath Mangeshkar Hospital and Research Centre
NOT_YET_RECRUITING

Pune, 411004, India
Diabetes & Endocrinology Associates of Stark County
NOT_YET_RECRUITING

Canton, Ohio, 44718, United States
Diabetes Care and Research Centre
NOT_YET_RECRUITING

Nagpur, 440010, India
Diabetes Heart Research Centre
NOT_YET_RECRUITING

Toronto, Ontario, M6G 1M2, Canada
Diablo Clinical Research
RECRUITING

Walnut Creek, California, 94598, United States
ERA Health Research - Redmond
RECRUITING

Redmond, Washington, 98052, United States
Elite Clinical Trials - Blackfoot
NOT_YET_RECRUITING

Blackfoot, Idaho, 83221, United States
Ellipsis Research Group - Brooklyn
NOT_YET_RECRUITING

Brooklyn, New York, 11215, United States
Encompass Clinical Research, Spring Valley
RECRUITING

Spring Valley, California, 91978, United States
Encore Medical Research
RECRUITING

Hollywood, Florida, 33024, United States
Encore Medical Research - Weston
RECRUITING

Weston, Florida, 33331, United States
Endocrine and Metabolic Consultants
NOT_YET_RECRUITING

Rockville, Maryland, 20852, United States
Endocrinologie Oasis Inc
RECRUITING

Montreal, Quebec, H4J 1E3, Canada
Evanston Premier Healthcare Research LLC
NOT_YET_RECRUITING

Skokie, Illinois, 60077, United States
Family First Clinical Research
NOT_YET_RECRUITING

Idaho Falls, Idaho, 83404, United States
Focus Clinical Research
RECRUITING

West Hills, California, 91307, United States
Fomat Medical Research
NOT_YET_RECRUITING

Oxnard, California, 93030, United States
Fraser Clinical Trials
RECRUITING

New Westminster, British Columbia, V3L 3W4, Canada
Gujarat Endocrine Centre
NOT_YET_RECRUITING

Ahmedabad, 380006, India
Helios Clinical Research - Paradise Valley
NOT_YET_RECRUITING

Paradise Valley, Arizona, 85253, United States
Helios Clinical Research - Phoenix
NOT_YET_RECRUITING

Phoenix, Arizona, 85028, United States
Heritage Valley Medical Group
NOT_YET_RECRUITING

Beaver, Pennsylvania, 15009, United States
Infinity Clinical Research
NOT_YET_RECRUITING

Norco, California, 92860, United States
International Diabetes Center
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55416, United States
Isis Clinical Research Center
NOT_YET_RECRUITING

Guaynabo, 00968, Puerto Rico
Javara Inc. - Cape Fear Valley Medical Center
NOT_YET_RECRUITING

Fayetteville, North Carolina, 28304, United States
Javara-Fayetteville-67354
RECRUITING

Fayetteville, Georgia, 30214, United States
John Muir Physician Network Clinical Research Center
RECRUITING

Concord, California, 94520, United States
Jothydev's Diabetes Research Centre
NOT_YET_RECRUITING

Trivandrum, 695032, India
Juno Research, LLC
NOT_YET_RECRUITING

Houston, Texas, 77040, United States
LifeDoc Research, PLLC
NOT_YET_RECRUITING

Memphis, Tennessee, 38115, United States
Logan Health Research - Kalispell
NOT_YET_RECRUITING

Kalispell, Montana, 59901, United States
Logan Hospital
NOT_YET_RECRUITING

Meadowbrook, Queensland, 4131, Australia
Metabolic Research Institute, Inc.
NOT_YET_RECRUITING

West Palm Beach, Florida, 33401, United States
Mission Research Institute - Gilbert
NOT_YET_RECRUITING

Gilbert, Arizona, 85296, United States
Momentum Clinical Research Dunedin
NOT_YET_RECRUITING

Central Dunedin, Dunedin, 9016, New Zealand
Neighborhood Healthcare - Escondido
NOT_YET_RECRUITING

Escondido, California, 92025, United States
New Horizon Research Center-Miami-69732
NOT_YET_RECRUITING

Miami, Florida, 33165, United States
New Venture Medical Research
NOT_YET_RECRUITING

Wadsworth, Ohio, 44281, United States
New Zealand Clinical Research (NZCR) Christchurch
NOT_YET_RECRUITING

Christchurch Central City, Christchurch, 8011, New Zealand
Northeast Research Institute
NOT_YET_RECRUITING

Fleming Island, Florida, 32003, United States
Northeast Research Institute
NOT_YET_RECRUITING

Jacksonville, Florida, 32204, United States
Northern Pines Health Center - Buckley
NOT_YET_RECRUITING

Buckley, Michigan, 49620, United States
Olive Branch Family Medical Center
NOT_YET_RECRUITING

Olive Branch, Mississippi, 38654, United States
Olympus Family Medicine
RECRUITING

Salt Lake City, Utah, 84117, United States
Osmania Medical College & Hospital
NOT_YET_RECRUITING

Hyderabad, Afzalgunj, 500012, India
Pacific Diabetes & Endocrine Center
NOT_YET_RECRUITING

Honolulu, Hawaii, 96817, United States
Palm Research Center
NOT_YET_RECRUITING

Las Vegas, Nevada, 89128, United States
PanAmerican Clinical Research - Bluffton
NOT_YET_RECRUITING

Bluffton, South Carolina, 29910, United States
PharmQuest Life Sciences
NOT_YET_RECRUITING

Greensboro, North Carolina, 27408, United States
Pinnacle Clinical Research - Georgetown
RECRUITING

Georgetown, Texas, 78626, United States
Pinnacle Clinical Research - San Antonio
RECRUITING

San Antonio, Texas, 78222, United States
Pinnacle Clinical Research, LLC
NOT_YET_RECRUITING

San Antonio, Texas, 78229, United States
Preferred Primary Care Physicians
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15243, United States
Preferred Primary Care Physicians - Matthew Drive
NOT_YET_RECRUITING

Uniontown, Pennsylvania, 15401, United States
Preferred Primary Care Physicians-Pittsburgh-63932
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15236, United States
Privia Medical Group Gulf Coast, PLLC
RECRUITING

Conroe, Texas, 77384, United States
Recherche Clinique Sigma Inc.
RECRUITING

Québec, G1G 5X1, Canada
Research Physicians Network
NOT_YET_RECRUITING

Houston, Texas, 77089, United States
Revival Research Institute, LLC - Dearborn
RECRUITING

Dearborn, Michigan, 48126, United States
Rophe Adult and Pediatric Medicine
NOT_YET_RECRUITING

Union City, Georgia, 30291, United States
Royal Prince Alfred Hospital
NOT_YET_RECRUITING

Camperdown, New South Wales, 2050, Australia
S.C.B. Medical College & Hospital
NOT_YET_RECRUITING

Cuttack, 753007, India
SKY Clinical Research Network Group - Ridgeland
NOT_YET_RECRUITING

Ridgeland, Mississippi, 39157, United States
San Fernando Valley Health
NOT_YET_RECRUITING

Canoga Park, California, 91304, United States
Sanjay Gandhi Post Graduate Institute of Medical Sciences
NOT_YET_RECRUITING

Lucknow, 226 014, India
Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
NOT_YET_RECRUITING

Ahmedabad, 380006, India
Shree Mahalaxmi Diatone Institute
NOT_YET_RECRUITING

Kolhāpur, 416003, India
Solaris Clinical Research
NOT_YET_RECRUITING

Meridian, Idaho, 83646, United States
South Broward Research
NOT_YET_RECRUITING

Miramar, Florida, 33027, United States
South Texas Research Institute - Brownsville
NOT_YET_RECRUITING

Brownsville, Texas, 78520, United States
Southern Adelaide Diabetes & Endocrine services
NOT_YET_RECRUITING

Oaklands Park, South Australia, 5046, Australia
Southern Endocrinology Associates
NOT_YET_RECRUITING

Mesquite, Texas, 75149, United States
Spartanburg Medical Research
NOT_YET_RECRUITING

Spartanburg, South Carolina, 29303, United States
StudyMetrix Research, LLC
NOT_YET_RECRUITING

City of Saint Peters, Missouri, 63303, United States
Supe Heart & Diabetes Hospital & Research Centre
NOT_YET_RECRUITING

Nashik, 422002, India
Tampa Bay Medical Research - Largo
RECRUITING

Largo, Florida, 33777, United States
Tekton Research Oklahoma City
RECRUITING

Oklahoma City, Oklahoma, 73134, United States
Texas Diabetes and Endocrinology - Central Austin
RECRUITING

Austin, Texas, 78731, United States
Texas Valley Clinical Research
NOT_YET_RECRUITING

Weslaco, Texas, 78596, United States
Tidewater Physicians Multispecialty Group
NOT_YET_RECRUITING

Newport News, Virginia, 23606, United States
University Clinical Investigators, Inc.
NOT_YET_RECRUITING

Tustin, California, 92780, United States
University Diabetes & Endocrine Consultants
RECRUITING

Chattanooga, Tennessee, 37411, United States
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING

Dallas, Texas, 75390-8837, United States
Valley Clinical Trials, Inc.
RECRUITING

Northridge, California, 91325, United States
Vishakha Institute of Medical Sciences
NOT_YET_RECRUITING

Visakhapatnam, 530040, India
Waitemata Clinical Research
NOT_YET_RECRUITING

Auckland, 0626, New Zealand
Woodland International Research Group, Inc.
RECRUITING

Little Rock, Arkansas, 72211, United States

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