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NCT07754461PHASE3Recruiting

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

Boehringer Ingelheim

Start Date

8/24/2026

Completion Date

5/1/2028

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. 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Placebo

DRUG

Survodutide

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Type 2 Diabetes

Locations

Cahaba Research, Inc. - Trussville Location

Birmingham, Alabama 35235

United States

Mission Research Institute - Gilbert

Gilbert, Arizona 85296

United States

Helios Clinical Research - Paradise Valley

Paradise Valley, Arizona 85253

United States

Arizona Liver Health - Peoria 85381

Peoria, Arizona 85381

United States

Helios Clinical Research - Phoenix

Phoenix, Arizona 85028

United States

Woodland International Research Group, Inc.

Little Rock, Arkansas 72211

United States

San Fernando Valley Health

Canoga Park, California 91304

United States

John Muir Physician Network Clinical Research Center

Concord, California 94520

United States

Neighborhood Healthcare - Escondido

Escondido, California 92025

United States

Clinical Trials Research - Lincoln

Lincoln, California 95648

United States

ARK Clinical Research

Long Beach, California 90815

United States

Infinity Clinical Research

Norco, California 92860

United States

Valley Clinical Trials, Inc.

Northridge, California 91325

United States

Fomat Medical Research

Oxnard, California 93030

United States

Encompass Clinical Research, Spring Valley

Spring Valley, California 91978

United States

University Clinical Investigators, Inc.

Tustin, California 92780

United States

Diablo Clinical Research

Walnut Creek, California 94598

United States

Focus Clinical Research

West Hills, California 91307

United States

Clinical Research of West Florida, Inc.

Clearwater, Florida 33765

United States

Northeast Research Institute

Fleming Island, Florida 32003

United States

Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida 33912

United States

Encore Medical Research

Hollywood, Florida 33024

United States

Northeast Research Institute

Jacksonville, Florida 32204

United States

Accel Research Sites - Lakeland

Lakeland, Florida 33803

United States

Clinical Research of Central Florida - Lakeland

Lakeland, Florida 33805

United States

Tampa Bay Medical Research - Largo

Largo, Florida 33777

United States

New Horizon Research Center-Miami-69732

Miami, Florida 33165

United States

South Broward Research

Miramar, Florida 33027

United States

Covenant Metabolic Specialists, LLC - Brandon

Riverview, Florida 33578

United States

Covenant Metabolic Specialists, LLC - Sarasota

University Park, Florida 34201

United States

Metabolic Research Institute, Inc.

West Palm Beach, Florida 33401

United States

Encore Medical Research - Weston

Weston, Florida 33331

United States

Conquest Research

Winter Park, Florida 32789

United States

Centricity Research, Endocrine Consultants

Columbus, Georgia 31904

United States

Javara-Fayetteville-67354

Fayetteville, Georgia 30214

United States

Balanced Life Health Care Solutions

Lawrenceville, Georgia 30046

United States

Rophe Adult and Pediatric Medicine

Union City, Georgia 30291

United States

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii 96817

United States

Elite Clinical Trials - Blackfoot

Blackfoot, Idaho 83221

United States

Family First Clinical Research

Idaho Falls, Idaho 83404

United States

Solaris Clinical Research

Meridian, Idaho 83646

United States

Evanston Premier Healthcare Research LLC

Skokie, Illinois 60077

United States

Cotton O'Neil Mulvane

Topeka, Kansas 66606

United States

AMR Lexington

Lexington, Kentucky 40509

United States

Endocrine and Metabolic Consultants

Rockville, Maryland 20852

United States

Northern Pines Health Center - Buckley

Buckley, Michigan 49620

United States

Revival Research Institute, LLC - Dearborn

Dearborn, Michigan 48126

United States

Arcturus Healthcare - Troy Internal Medicine Research Division

Troy, Michigan 48098

United States

International Diabetes Center

Minneapolis, Minnesota 55416

United States

Olive Branch Family Medical Center

Olive Branch, Mississippi 38654

United States

SKY Clinical Research Network Group - Ridgeland

Ridgeland, Mississippi 39157

United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri 63303

United States

Logan Health Research - Kalispell

Kalispell, Montana 59901

United States

Boeson Research - Missoula

Missoula, Montana 59804

United States

Palm Research Center

Las Vegas, Nevada 89128

United States

Albuquerque Clinical Trials

Albuquerque, New Mexico 87102

United States

Ellipsis Research Group - Brooklyn

Brooklyn, New York 11215

United States

Javara Inc. - Cape Fear Valley Medical Center

Fayetteville, North Carolina 28304

United States

PharmQuest Life Sciences

Greensboro, North Carolina 27408

United States

Centricity Research - Morehead City

Morehead City, North Carolina 28557

United States

Diabetes & Endocrinology Associates of Stark County

Canton, Ohio 44718

United States

Advanced Medical Research - Maumee

Maumee, Ohio 43537

United States

New Venture Medical Research

Wadsworth, Ohio 44281

United States

Tekton Research Oklahoma City

Oklahoma City, Oklahoma 73134

United States

Heritage Valley Medical Group

Beaver, Pennsylvania 15009

United States

Preferred Primary Care Physicians-Pittsburgh-63932

Pittsburgh, Pennsylvania 15236

United States

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania 15243

United States

Preferred Primary Care Physicians - Matthew Drive

Uniontown, Pennsylvania 15401

United States

PanAmerican Clinical Research - Bluffton

Bluffton, South Carolina 29910

United States

Spartanburg Medical Research

Spartanburg, South Carolina 29303

United States

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee 37411

United States

LifeDoc Research, PLLC

Memphis, Tennessee 38115

United States

Texas Diabetes and Endocrinology - Central Austin

Austin, Texas 78731

United States

South Texas Research Institute - Brownsville

Brownsville, Texas 78520

United States

Privia Medical Group Gulf Coast, PLLC

Conroe, Texas 77384

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390-8837

United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas 78626

United States

Juno Research, LLC

Houston, Texas 77040

United States

Biopharma Informatic, Inc. Research Center

Houston, Texas 77084

United States

Research Physicians Network

Houston, Texas 77089

United States

Southern Endocrinology Associates

Mesquite, Texas 75149

United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas 78222

United States

Pinnacle Clinical Research, LLC

San Antonio, Texas 78229

United States

Consano Clinical Research

Shavano Park, Texas 78231

United States

Texas Valley Clinical Research

Weslaco, Texas 78596

United States

Olympus Family Medicine

Salt Lake City, Utah 84117

United States

Tidewater Physicians Multispecialty Group

Newport News, Virginia 23606

United States

ERA Health Research - Redmond

Redmond, Washington 98052

United States

Clinical Investigation Specialists, Inc.-Kenosha-69111

Kenosha, Wisconsin 53144

United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Logan Hospital

Meadowbrook, Queensland 4131

Australia

Southern Adelaide Diabetes & Endocrine services

Oaklands Park, South Australia 5046

Australia

Baker Heart and Diabetes Institute

Melbourne, Victoria 3004

Australia

Fraser Clinical Trials

New Westminster, British Columbia V3L 3W4

Canada

Centricity Research (Brampton)

Brampton, Ontario L6S 0C6

Canada

Centricity Research (Vaughan)

Concord, Ontario L4K 4M2

Canada

Centricity Research (Nepean)

Nepean, Ontario K2J 0V2

Canada

Centricity Research (Bayview)

Toronto, Ontario M4G 3E8

Canada

Diabetes Heart Research Centre

Toronto, Ontario M6G 1M2

Canada

Albion Finch Medical Centre

Toronto, Ontario M9V 4B4

Canada

Applied Medical Informatics Research Inc.

Montreal, Quebec H4A 3T2

Canada

Endocrinologie Oasis Inc

Montreal, Quebec H4J 1E3

Canada

Recherche Clinique Sigma Inc.

Québec, G1G 5X1

Canada

Gujarat Endocrine Centre

Ahmedabad, 380006

India

Sardar Vallabhbhai Patel Institute of Medical Sciences and Research

Ahmedabad, 380006

India

AIIMS Bhubaneshwar

Bhubaneswar, 751019

India

S.C.B. Medical College & Hospital

Cuttack, 753007

India

Osmania Medical College & Hospital

Hyderabad, Afzalgunj, 500012

India

Shree Mahalaxmi Diatone Institute

Kolhāpur, 416003

India

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, 226 014

India

Diabetes Care and Research Centre

Nagpur, 440010

India

Supe Heart & Diabetes Hospital & Research Centre

Nashik, 422002

India

AIIMS, New Delhi

New Delhi, 110029

India

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004

India

Jothydev's Diabetes Research Centre

Trivandrum, 695032

India

Vishakha Institute of Medical Sciences

Visakhapatnam, 530040

India

New Zealand Clinical Research (NZCR) Christchurch

Christchurch Central City, Christchurch 8011

New Zealand

Momentum Clinical Research Dunedin

Central Dunedin, Dunedin 9016

New Zealand

Waitemata Clinical Research

Auckland, 0626

New Zealand

Clinical Trials New Zealand Ltd

Hamilton, 3204

New Zealand

Isis Clinical Research Center

Guaynabo, 00968

Puerto Rico