What this trial means for you
This study is recruiting now at 89 US sites. It's studying Placebo, Survodutide for type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Alabama
- Cahaba Research, Inc. - Trussville Location, Birmingham · Opening soon
Arizona
- Mission Research Institute - Gilbert, Gilbert · Opening soon
- Helios Clinical Research - Paradise Valley, Paradise Valley · Opening soon
- Arizona Liver Health - Peoria 85381, Peoria · Opening soon
- Helios Clinical Research - Phoenix, Phoenix · Opening soon
Arkansas
- Woodland International Research Group, Inc., Little Rock · Opening soon
California
- San Fernando Valley Health, Canoga Park · Opening soon
- John Muir Physician Network Clinical Research Center, Concord · Opening soon
- Neighborhood Healthcare - Escondido, Escondido · Opening soon
- Clinical Trials Research - Lincoln, Lincoln · Opening soon
- ARK Clinical Research, Long Beach · Opening soon
- Infinity Clinical Research, Norco · Opening soon
- Valley Clinical Trials, Inc., Northridge · Recruiting now
- Fomat Medical Research, Oxnard · Opening soon
- Encompass Clinical Research, Spring Valley, Spring Valley · Opening soon
- University Clinical Investigators, Inc., Tustin · Opening soon
- Diablo Clinical Research, Walnut Creek · Recruiting now
- Focus Clinical Research, West Hills · Opening soon
Florida
- Clinical Research of West Florida, Inc., Clearwater · Recruiting now
- Northeast Research Institute, Fleming Island · Opening soon
- Covenant Metabolic Specialists, LLC - Fort Myers, Fort Myers · Recruiting now
- Encore Medical Research, Hollywood · Opening soon
- Northeast Research Institute, Jacksonville · Opening soon
- Accel Research Sites - Lakeland, Lakeland · Opening soon
- Clinical Research of Central Florida - Lakeland, Lakeland · Opening soon
- Tampa Bay Medical Research - Largo, Largo · Opening soon
- New Horizon Research Center-Miami-69732, Miami · Opening soon
- South Broward Research, Miramar · Opening soon
- Covenant Metabolic Specialists, LLC - Brandon, Riverview · Recruiting now
- Covenant Metabolic Specialists, LLC - Sarasota, University Park · Recruiting now
- Metabolic Research Institute, Inc., West Palm Beach · Opening soon
- Encore Medical Research - Weston, Weston · Opening soon
- Conquest Research, Winter Park · Opening soon
Georgia
- Centricity Research, Endocrine Consultants, Columbus · Opening soon
- Javara-Fayetteville-67354, Fayetteville · Opening soon
- Balanced Life Health Care Solutions, Lawrenceville · Opening soon
- Rophe Adult and Pediatric Medicine, Union City · Opening soon
Hawaii
- Pacific Diabetes & Endocrine Center, Honolulu · Opening soon
Idaho
- Elite Clinical Trials - Blackfoot, Blackfoot · Opening soon
- Family First Clinical Research, Idaho Falls · Opening soon
- Solaris Clinical Research, Meridian · Opening soon
Illinois
- Evanston Premier Healthcare Research LLC, Skokie · Opening soon
Kansas
- Cotton O'Neil Mulvane, Topeka · Opening soon
Kentucky
- AMR Lexington, Lexington · Opening soon
Maryland
- Endocrine and Metabolic Consultants, Rockville · Opening soon
Michigan
- Northern Pines Health Center - Buckley, Buckley · Opening soon
- Revival Research Institute, LLC - Dearborn, Dearborn · Opening soon
- Arcturus Healthcare - Troy Internal Medicine Research Division, Troy · Opening soon
Minnesota
- International Diabetes Center, Minneapolis · Opening soon
Mississippi
- Olive Branch Family Medical Center, Olive Branch · Opening soon
- SKY Clinical Research Network Group - Ridgeland, Ridgeland · Opening soon
Missouri
- StudyMetrix Research, LLC, City of Saint Peters · Opening soon
Montana
- Logan Health Research - Kalispell, Kalispell · Opening soon
- Boeson Research - Missoula, Missoula · Opening soon
Nevada
- Palm Research Center, Las Vegas · Opening soon
New Mexico
- Albuquerque Clinical Trials, Albuquerque · Opening soon
New York
- Ellipsis Research Group - Brooklyn, Brooklyn · Opening soon
North Carolina
- Cape Fear Valley Medical Center, Fayetteville · Opening soon
- PharmQuest Life Sciences, Greensboro · Opening soon
- Centricity Research - Morehead City, Morehead City · Opening soon
Ohio
- Diabetes & Endocrinology Associates of Stark County, Canton · Opening soon
- Advanced Medical Research - Maumee, Maumee · Opening soon
- New Venture Medical Research, Wadsworth · Opening soon
Oklahoma
- Tekton Research-Edmond-68875, Edmond · Opening soon
Pennsylvania
- Heritage Valley Medical Group, Beaver · Opening soon
- Preferred Primary Care Physicians-Pittsburgh-63932, Pittsburgh · Opening soon
- Preferred Primary Care Physicians, Pittsburgh · Opening soon
- Preferred Primary Care Physicians - Matthew Drive, Uniontown · Opening soon
South Carolina
- PanAmerican Clinical Research - Bluffton, Bluffton · Opening soon
- Spartanburg Medical Research, Spartanburg · Opening soon
Tennessee
- University Diabetes & Endocrine Consultants, Chattanooga · Opening soon
- LifeDoc Research, PLLC, Memphis · Opening soon
Texas
- Texas Diabetes and Endocrinology, Austin · Recruiting now
- South Texas Research Institute - Brownsville, Brownsville · Opening soon
- Privia Medical Group Gulf Coast, PLLC, Conroe · Opening soon
- University of Texas Southwestern Medical Center, Dallas · Opening soon
- Pinnacle Clinical Research - Georgetown, Georgetown · Opening soon
- Juno Research, LLC, Houston · Opening soon
- Biopharma Informatic, Inc. Research Center, Houston · Opening soon
- Research Physicians Network, Houston · Opening soon
- Southern Endocrinology Associates, Mesquite · Opening soon
- Pinnacle Clinical Research - San Antonio, San Antonio · Opening soon
- Pinnacle Clinical Research, LLC, San Antonio · Opening soon
- Consano Clinical Research, Shavano Park · Opening soon
- Texas Valley Clinical Research, Weslaco · Opening soon
Utah
- Olympus Family Medicine, Salt Lake City · Opening soon
Virginia
- Tidewater Physicians Multispecialty Group, Newport News · Opening soon
Washington
- ERA Health Research - Redmond, Redmond · Opening soon
Wisconsin
- Clinical Investigation Specialists, Inc.-Kenosha-69111, Kenosha · Opening soon
View the official record on ClinicalTrials.gov →
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