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

NCT07754461 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 1404-0115
• Study Type: interventional
• Target: 600
• Locations: 6 countries
• Sites: 115

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41

  At baseline and Week 41.

Secondary Outcomes (11)

• Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53

  At baseline and Week 53.

• Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41

  At baseline and Week 41.

• Achievement of HbA1c <5.7% (yes/no) at Week 41

  At Week 41.

• Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53

  At baseline and Week 53.

• Percent change in body weight (kg) from baseline to Week 53

  At baseline and Week 53.

Study Arms (9)

Part A: Placebo

PLACEBO COMPARATOR

Placebo as an add-on to diet and exercise.

Drug: Placebo

Part A: Low-dose survodutide

EXPERIMENTAL

Low-dose survodutide as an add-on to diet and exercise.

Drug: Survodutide

Part A: High-dose survodutide

EXPERIMENTAL

High-dose survodutide as add-on to diet and exercise

Drug: Survodutide

Part B: Placebo

PLACEBO COMPARATOR

Placebo as an add-on to anti-diabetic drugs.

Drug: Placebo

Part B: Low-dose survodutide

EXPERIMENTAL

Low-dose survodutide as an add-on to anti-diabetic drugs.

Drug: Survodutide

Part B: High-dose survodutide

EXPERIMENTAL

High-dose survodutide as an add-on to anti-diabetic drugs.

Drug: Survodutide

Part C: Placebo

PLACEBO COMPARATOR

Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.

Drug: Placebo

Part C: Low-dose survodutide

EXPERIMENTAL

Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.

Drug: Survodutide

Part C: High-dose survodutide

EXPERIMENTAL

High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.

Drug: Survodutide

Interventions

Placebo DRUG

Placebo

Part A: Placebo; Part B: Placebo; Part C: Placebo

Survodutide DRUG

Survodutide

Also known as: BI 456906

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• Type 1 diabetes mellitus (T1D) or latent autoimmune diabetes in adults (LADA)
• 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)
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (115)

Cahaba Research, Inc. - Trussville Location

Birmingham, Alabama, 35235, United States

Location

Gilbert Center for Family Medicine

Gilbert, Arizona, 85296, United States

Location

Helios Clinical Research - Paradise Valley

Paradise Valley, Arizona, 85253, United States

Location

Arizona Liver Health - Peoria 85381

Peoria, Arizona, 85381, United States

Location

Helios Clinical Research - Phoenix

Phoenix, Arizona, 85028, United States

Location

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72211, United States

Location

San Fernando Valley Health

Canoga Park, California, 91304, United States

Location

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

Neighborhood Healthcare - Escondido

Escondido, California, 92025, United States

Location

Clinical Trials Research - Lincoln

Lincoln, California, 95648, United States

Location

ARK Clinical Research

Long Beach, California, 90815, United States

Location

Infinity Clinical Research

Norco, California, 92860, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Fomat Medical Research

Oxnard, California, 93030, United States

Location

Encompass Clinical Research, Spring Valley

Spring Valley, California, 91978, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Focus Clinical Research

West Hills, California, 91307, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Northeast Research Institute

Fleming Island, Florida, 32003, United States

Location

Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida, 33912, United States

Location

Encore Medical Research

Hollywood, Florida, 33024, United States

Location

Northeast Research Institute

Jacksonville, Florida, 32204, United States

Location

Accel Research Sites - Lakeland

Lakeland, Florida, 33803, United States

Location

Clinical Research of Central Florida - Lakeland

Lakeland, Florida, 33805, United States

Location

Tampa Bay Medical Research - Largo

Largo, Florida, 33777, United States

Location

New Horizon Research Center-Miami-69732

Miami, Florida, 33165, United States

Location

South Broward Research

Miramar, Florida, 33027, United States

Location

Covenant Metabolic Specialists, LLC - Brandon

Riverview, Florida, 33578, United States

Location

Covenant Metabolic Specialists, LLC - Sarasota

University Park, Florida, 34201, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Encore Medical Research - Weston

Weston, Florida, 33331, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Centricity Research, Endocrine Consultants

Columbus, Georgia, 31904, United States

Location

Javara-Fayetteville-67354

Fayetteville, Georgia, 30214, United States

Location

Balanced Life Health Care Solutions

Lawrenceville, Georgia, 30046, United States

Location

Rophe Adult and Pediatric Medicine

Union City, Georgia, 30291, United States

Location

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, 96817, United States

Location

Elite Clinical Trials - Blackfoot

Blackfoot, Idaho, 83221, United States

Location

Family First Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Evanston Premier Healthcare Research LLC

Skokie, Illinois, 60077, United States

Location

Cotton O'Neil Mulvane

Topeka, Kansas, 66606, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

Endocrine and Metabolic Consultants

Rockville, Maryland, 20852, United States

Location

Northern Pines Health Center - Buckley

Buckley, Michigan, 49620, United States

Location

Revival Research Institute, LLC - Dearborn

Dearborn, Michigan, 48126, United States

Location

Arcturus Healthcare - Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

SKY Clinical Research Network Group - Ridgeland

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303, United States

Location

Logan Health Research - Kalispell

Kalispell, Montana, 59901, United States

Location

Boeson Research - Missoula

Missoula, Montana, 59804, United States

Location

Palm Research Center

Las Vegas, Nevada, 89128, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Ellipsis Research Group - Brooklyn

Brooklyn, New York, 11215, United States

Location

Cape Fear Valley Medical Center

Fayetteville, North Carolina, 28304, United States

Location

PharmQuest Life Sciences

Greensboro, North Carolina, 27408, United States

Location

Centricity Research - Morehead City

Morehead City, North Carolina, 28557, United States

Location

Diabetes & Endocrinology Associates of Stark County

Canton, Ohio, 44718, United States

Location

Advanced Medical Research - Maumee

Maumee, Ohio, 43537, United States

Location

New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

Tekton Research-Edmond-68875

Edmond, Oklahoma, 73013, United States

Location

Heritage Valley Medical Group

Beaver, Pennsylvania, 15009, United States

Location

Preferred Primary Care Physicians-Pittsburgh-63932

Pittsburgh, Pennsylvania, 15236, United States

Location

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15243, United States

Location

Preferred Primary Care Physicians - Matthew Drive

Uniontown, Pennsylvania, 15401, United States

Location

PanAmerican Clinical Research - Bluffton

Bluffton, South Carolina, 29910, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

LifeDoc Research, PLLC

Memphis, Tennessee, 38115, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

South Texas Research Institute - Brownsville

Brownsville, Texas, 78520, United States

Location

Privia Medical Group Gulf Coast, PLLC

Conroe, Texas, 77384, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8837, United States

Location

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, 78626, United States

Location

Juno Research, LLC

Houston, Texas, 77040, United States

Location

Biopharma Informatic, Inc. Research Center

Houston, Texas, 77084, United States

Location

Research Physicians Network

Houston, Texas, 77089, United States

Location

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

Location

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78222, United States

Location

Pinnacle Clinical Research, LLC

San Antonio, Texas, 78229, United States

Location

Consano Clinical Research

Shavano Park, Texas, 78231, United States

Location

Texas Valley Clinical Research

Weslaco, Texas, 78596, United States

Location

Olympus Family Medicine

Salt Lake City, Utah, 84117, United States

Location

Tidewater Physicians Multispecialty Group

Newport News, Virginia, 23606, United States

Location

ERA Health Research - Redmond

Redmond, Washington, 98052, United States

Location

Clinical Investigation Specialists, Inc.-Kenosha-69111

Kenosha, Wisconsin, 53144, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Logan Hospital

Meadowbrook, Queensland, 4131, Australia

Location

Southern Adelaide Diabetes & Endocrine services

Oaklands Park, South Australia, 5046, Australia

Location

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

Fraser Clinical Trials

New Westminster, British Columbia, V3L 3W4, Canada

Location

Centricity Research (Brampton)

Brampton, Ontario, L6S 0C6, Canada

Location

Centricity Research (Vaughan)

Concord, Ontario, L4K 4M2, Canada

Location

Centricity Research (Nepean)

Nepean, Ontario, K2J 0V2, Canada

Location

Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada

Location

Albion Finch Medical Centre

Toronto, Ontario, M9V 4B4, Canada

Location

Applied Medical Informatics Research Inc.

Montreal, Quebec, H4A 3T2, Canada

Location

Endocrinologie Oasis Inc

Montreal, Quebec, H4J 1E3, Canada

Location

Recherche Clinique Sigma Inc.

Québec, G1G 5X1, Canada

Location

Gujarat Endocrine Centre

Ahmedabad, 380006, India

Location

AIIMS Bhubaneshwar

Bhubaneswar, 751019, India

Location

Osmania Medical College & Hospital

Hyderabad, Afzalgunj, 500012, India

Location

Diabetes Care and Research Centre

Nagpur, 440010, India

Location

Supe Heart & Diabetes Hospital & Research Centre

Nashik, 422002, India

Location

AIIMS, New Delhi

New Delhi, 110029, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, 411004, India

Location

Jothydev's Diabetes Research Centre

Trivandrum, 695032, India

Location

New Zealand Clinical Research (NZCR) Christchurch

Christchurch Central City, Christchurch, 8011, New Zealand

Location

Momentum Clinical Research Dunedin

Dunedin, Otago, 9016, New Zealand

Location

Waitemata Clinical Research

Auckland, 0626, New Zealand

Location

Clinical Trials New Zealand Ltd

Hamilton, 3204, New Zealand

Location

Isis Clinical Research Center

Guaynabo, 00968, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 24, 2026
• Primary Completion (Estimated): January 17, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

IN (8); AU (4); PR (1); CA (9); NZ (4); US (89)