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

16 septembre 2026 mis à jour par: Boehringer Ingelheim

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.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

600

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Australie
    • New South Wales
      • Camperdown, New South Wales, Australie, 2050
        • Pas encore de recrutement
        • Royal Prince Alfred Hospital
        • Contact:
    • Queensland
      • Meadowbrook, Queensland, Australie, 4131
        • Pas encore de recrutement
        • Logan Hospital
        • Contact:
    • South Australia
      • Oaklands Park, South Australia, Australie, 5046
        • Pas encore de recrutement
        • Southern Adelaide Diabetes & Endocrine services
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australie, 3004
        • Pas encore de recrutement
        • Baker Heart and Diabetes Institute
        • Contact:
  • Canada
      • Québec, Canada, G1G 5X1
        • Recrutement
        • Recherche Clinique Sigma Inc.
        • Contact:
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Recrutement
        • Fraser Clinical Trials
        • Contact:
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Recrutement
        • Centricity Research (Brampton)
        • Contact:
      • Concord, Ontario, Canada, L4K 4M2
        • Pas encore de recrutement
        • Centricity Research (Vaughan)
        • Contact:
      • Nepean, Ontario, Canada, K2J 0V2
        • Pas encore de recrutement
        • Centricity Research (Nepean)
        • Contact:
      • Toronto, Ontario, Canada, M9V 4B4
        • Pas encore de recrutement
        • Albion Finch Medical Centre
        • Contact:
      • Toronto, Ontario, Canada, M6G 1M2
        • Pas encore de recrutement
        • Diabetes Heart Research Centre
        • Contact:
      • Toronto, Ontario, Canada, M4G 3E8
        • Pas encore de recrutement
        • Centricity Research (Bayview)
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4J 1E3
        • Recrutement
        • Endocrinologie Oasis Inc
        • Contact:
      • Montreal, Quebec, Canada, H4A 3T2
        • Pas encore de recrutement
        • Applied Medical Informatics Research Inc.
        • Contact:
  • Inde
      • Ahmedabad, Inde, 380006
        • Pas encore de recrutement
        • Gujarat Endocrine Centre
        • Contact:
      • Ahmedabad, Inde, 380006
        • Pas encore de recrutement
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Contact:
      • Bhubaneswar, Inde, 751019
        • Pas encore de recrutement
        • AIIMS Bhubaneshwar
        • Contact:
      • Cuttack, Inde, 753007
        • Pas encore de recrutement
        • S.C.B. Medical College & Hospital
        • Contact:
      • Hyderabad, Afzalgunj, Inde, 500012
        • Pas encore de recrutement
        • Osmania Medical College & Hospital
        • Contact:
      • Kolhāpur, Inde, 416003
        • Pas encore de recrutement
        • Shree Mahalaxmi Diatone Institute
        • Contact:
      • Lucknow, Inde, 226 014
        • Pas encore de recrutement
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Contact:
      • Nagpur, Inde, 440010
        • Pas encore de recrutement
        • Diabetes Care and Research Centre
        • Contact:
      • Nashik, Inde, 422002
        • Pas encore de recrutement
        • Supe Heart & Diabetes Hospital & Research Centre
        • Contact:
      • New Delhi, Inde, 110029
        • Pas encore de recrutement
        • AIIMS, New Delhi
        • Contact:
      • Pune, Inde, 411004
        • Pas encore de recrutement
        • Deenanath Mangeshkar Hospital and Research Centre
        • Contact:
      • Trivandrum, Inde, 695032
        • Pas encore de recrutement
        • Jothydev's Diabetes Research Centre
        • Contact:
      • Visakhapatnam, Inde, 530040
        • Pas encore de recrutement
        • Vishakha Institute of Medical Sciences
        • Contact:
  • Nouvelle-Zélande
      • Auckland, Nouvelle-Zélande, 0626
        • Pas encore de recrutement
        • Waitemata Clinical Research
        • Contact:
      • Hamilton, Nouvelle-Zélande, 3204
        • Pas encore de recrutement
        • Clinical Trials New Zealand Ltd
        • Contact:
    • Christchurch
      • Christchurch Central City, Christchurch, Nouvelle-Zélande, 8011
        • Pas encore de recrutement
        • New Zealand Clinical Research (NZCR) Christchurch
        • Contact:
    • Dunedin
      • Central Dunedin, Dunedin, Nouvelle-Zélande, 9016
        • Pas encore de recrutement
        • Momentum Clinical Research Dunedin
        • Contact:
  • Porto Rico
      • Guaynabo, Porto Rico, 00968
        • Pas encore de recrutement
        • Isis Clinical Research Center
        • Contact:
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35235
        • Pas encore de recrutement
        • Cahaba Research, Inc. - Trussville Location
        • Contact:
    • Arizona
      • Gilbert, Arizona, États-Unis, 85296
        • Pas encore de recrutement
        • Mission Research Institute - Gilbert
        • Contact:
      • Paradise Valley, Arizona, États-Unis, 85253
        • Pas encore de recrutement
        • Helios Clinical Research - Paradise Valley
        • Contact:
      • Peoria, Arizona, États-Unis, 85381
        • Pas encore de recrutement
        • Arizona Liver Health - Peoria 85381
        • Contact:
      • Phoenix, Arizona, États-Unis, 85028
        • Pas encore de recrutement
        • Helios Clinical Research - Phoenix
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72211
        • Recrutement
        • Woodland International Research Group, Inc.
        • Contact:
    • California
      • Canoga Park, California, États-Unis, 91304
        • Pas encore de recrutement
        • San Fernando Valley Health
        • Contact:
      • Concord, California, États-Unis, 94520
        • Recrutement
        • John Muir Physician Network Clinical Research Center
        • Contact:
      • Escondido, California, États-Unis, 92025
        • Pas encore de recrutement
        • Neighborhood Healthcare - Escondido
        • Contact:
      • Lincoln, California, États-Unis, 95648
        • Pas encore de recrutement
        • Clinical Trials Research - Lincoln
        • Contact:
      • Long Beach, California, États-Unis, 90815
      • Norco, California, États-Unis, 92860
        • Pas encore de recrutement
        • Infinity Clinical Research
        • Contact:
      • Northridge, California, États-Unis, 91325
      • Oxnard, California, États-Unis, 93030
        • Pas encore de recrutement
        • Fomat Medical Research
        • Contact:
      • Spring Valley, California, États-Unis, 91978
        • Recrutement
        • Encompass Clinical Research, Spring Valley
        • Contact:
      • Tustin, California, États-Unis, 92780
        • Pas encore de recrutement
        • University Clinical Investigators, Inc.
        • Contact:
      • Walnut Creek, California, États-Unis, 94598
      • West Hills, California, États-Unis, 91307
    • Florida
      • Clearwater, Florida, États-Unis, 33765
        • Recrutement
        • Clinical Research of West Florida, Inc.
        • Contact:
      • Fleming Island, Florida, États-Unis, 32003
        • Pas encore de recrutement
        • Northeast Research Institute
        • Contact:
      • Fort Myers, Florida, États-Unis, 33912
        • Recrutement
        • Covenant Metabolic Specialists, LLC - Fort Myers
        • Contact:
      • Hollywood, Florida, États-Unis, 33024
      • Jacksonville, Florida, États-Unis, 32204
        • Pas encore de recrutement
        • Northeast Research Institute
        • Contact:
      • Lakeland, Florida, États-Unis, 33803
        • Pas encore de recrutement
        • Accel Research Sites - Lakeland
        • Contact:
      • Lakeland, Florida, États-Unis, 33805
        • Pas encore de recrutement
        • Clinical Research of Central Florida - Lakeland
        • Contact:
      • Largo, Florida, États-Unis, 33777
        • Recrutement
        • Tampa Bay Medical Research - Largo
        • Contact:
      • Miami, Florida, États-Unis, 33165
        • Pas encore de recrutement
        • New Horizon Research Center-Miami-69732
        • Contact:
      • Miramar, Florida, États-Unis, 33027
        • Pas encore de recrutement
        • South Broward Research
        • Contact:
      • Riverview, Florida, États-Unis, 33578
        • Recrutement
        • Covenant Metabolic Specialists, LLC - Brandon
        • Contact:
      • University Park, Florida, États-Unis, 34201
        • Recrutement
        • Covenant Metabolic Specialists, LLC - Sarasota
        • Contact:
      • West Palm Beach, Florida, États-Unis, 33401
        • Pas encore de recrutement
        • Metabolic Research Institute, Inc.
        • Contact:
      • Weston, Florida, États-Unis, 33331
      • Winter Park, Florida, États-Unis, 32789
    • Georgia
      • Columbus, Georgia, États-Unis, 31904
        • Recrutement
        • Centricity Research, Endocrine Consultants
        • Contact:
      • Fayetteville, Georgia, États-Unis, 30214
      • Lawrenceville, Georgia, États-Unis, 30046
        • Pas encore de recrutement
        • Balanced Life Health Care Solutions
        • Contact:
      • Union City, Georgia, États-Unis, 30291
        • Pas encore de recrutement
        • Rophe Adult and Pediatric Medicine
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96817
        • Pas encore de recrutement
        • Pacific Diabetes & Endocrine Center
        • Contact:
    • Idaho
      • Blackfoot, Idaho, États-Unis, 83221
        • Pas encore de recrutement
        • Elite Clinical Trials - Blackfoot
        • Contact:
      • Idaho Falls, Idaho, États-Unis, 83404
        • Pas encore de recrutement
        • Family First Clinical Research
        • Contact:
      • Meridian, Idaho, États-Unis, 83646
        • Pas encore de recrutement
        • Solaris Clinical Research
        • Contact:
    • Illinois
      • Skokie, Illinois, États-Unis, 60077
        • Pas encore de recrutement
        • Evanston Premier Healthcare Research LLC
        • Contact:
    • Kansas
      • Topeka, Kansas, États-Unis, 66606
        • Pas encore de recrutement
        • Cotton O'Neil Mulvane
        • Contact:
    • Kentucky
      • Lexington, Kentucky, États-Unis, 40509
    • Maryland
      • Rockville, Maryland, États-Unis, 20852
        • Pas encore de recrutement
        • Endocrine and Metabolic Consultants
        • Contact:
    • Michigan
      • Buckley, Michigan, États-Unis, 49620
        • Pas encore de recrutement
        • Northern Pines Health Center - Buckley
        • Contact:
      • Dearborn, Michigan, États-Unis, 48126
        • Recrutement
        • Revival Research Institute, LLC - Dearborn
        • Contact:
      • Troy, Michigan, États-Unis, 48098
        • Pas encore de recrutement
        • Arcturus Healthcare - Troy Internal Medicine Research Division
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55416
        • Pas encore de recrutement
        • International Diabetes Center
        • Contact:
    • Mississippi
      • Olive Branch, Mississippi, États-Unis, 38654
        • Pas encore de recrutement
        • Olive Branch Family Medical Center
        • Contact:
      • Ridgeland, Mississippi, États-Unis, 39157
        • Pas encore de recrutement
        • SKY Clinical Research Network Group - Ridgeland
        • Contact:
    • Missouri
      • City of Saint Peters, Missouri, États-Unis, 63303
        • Pas encore de recrutement
        • StudyMetrix Research, LLC
        • Contact:
    • Montana
      • Kalispell, Montana, États-Unis, 59901
        • Pas encore de recrutement
        • Logan Health Research - Kalispell
        • Contact:
      • Missoula, Montana, États-Unis, 59804
        • Pas encore de recrutement
        • Boeson Research - Missoula
        • Contact:
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89128
        • Pas encore de recrutement
        • Palm Research Center
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87102
        • Pas encore de recrutement
        • Albuquerque Clinical Trials
        • Contact:
    • New York
      • Brooklyn, New York, États-Unis, 11215
        • Pas encore de recrutement
        • Ellipsis Research Group - Brooklyn
        • Contact:
    • North Carolina
      • Fayetteville, North Carolina, États-Unis, 28304
        • Pas encore de recrutement
        • Javara Inc. - Cape Fear Valley Medical Center
        • Contact:
      • Greensboro, North Carolina, États-Unis, 27408
        • Pas encore de recrutement
        • PharmQuest Life Sciences
        • Contact:
      • Morehead City, North Carolina, États-Unis, 28557
        • Recrutement
        • Centricity Research - Morehead City
        • Contact:
    • Ohio
      • Canton, Ohio, États-Unis, 44718
        • Pas encore de recrutement
        • Diabetes & Endocrinology Associates of Stark County
        • Contact:
      • Maumee, Ohio, États-Unis, 43537
        • Pas encore de recrutement
        • Advanced Medical Research - Maumee
        • Contact:
      • Wadsworth, Ohio, États-Unis, 44281
        • Pas encore de recrutement
        • New Venture Medical Research
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73134
    • Pennsylvania
      • Beaver, Pennsylvania, États-Unis, 15009
        • Pas encore de recrutement
        • Heritage Valley Medical Group
        • Contact:
      • Pittsburgh, Pennsylvania, États-Unis, 15236
        • Pas encore de recrutement
        • Preferred Primary Care Physicians-Pittsburgh-63932
        • Contact:
      • Pittsburgh, Pennsylvania, États-Unis, 15243
        • Pas encore de recrutement
        • Preferred Primary Care Physicians
        • Contact:
      • Uniontown, Pennsylvania, États-Unis, 15401
        • Pas encore de recrutement
        • Preferred Primary Care Physicians - Matthew Drive
        • Contact:
    • South Carolina
      • Bluffton, South Carolina, États-Unis, 29910
        • Pas encore de recrutement
        • PanAmerican Clinical Research - Bluffton
        • Contact:
      • Spartanburg, South Carolina, États-Unis, 29303
        • Pas encore de recrutement
        • Spartanburg Medical Research
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, États-Unis, 37411
        • Recrutement
        • University Diabetes & Endocrine Consultants
        • Contact:
      • Memphis, Tennessee, États-Unis, 38115
        • Pas encore de recrutement
        • LifeDoc Research, PLLC
        • Contact:
    • Texas
      • Austin, Texas, États-Unis, 78731
        • Recrutement
        • Texas Diabetes and Endocrinology - Central Austin
        • Contact:
      • Brownsville, Texas, États-Unis, 78520
        • Pas encore de recrutement
        • South Texas Research Institute - Brownsville
        • Contact:
      • Conroe, Texas, États-Unis, 77384
        • Recrutement
        • Privia Medical Group Gulf Coast, PLLC
        • Contact:
      • Dallas, Texas, États-Unis, 75390-8837
        • Pas encore de recrutement
        • University of Texas Southwestern Medical Center
        • Contact:
      • Georgetown, Texas, États-Unis, 78626
        • Recrutement
        • Pinnacle Clinical Research - Georgetown
        • Contact:
      • Houston, Texas, États-Unis, 77040
      • Houston, Texas, États-Unis, 77084
        • Pas encore de recrutement
        • Biopharma Informatic, Inc. Research Center
        • Contact:
      • Houston, Texas, États-Unis, 77089
        • Pas encore de recrutement
        • Research Physicians Network
        • Contact:
      • Mesquite, Texas, États-Unis, 75149
        • Pas encore de recrutement
        • Southern Endocrinology Associates
        • Contact:
      • San Antonio, Texas, États-Unis, 78229
        • Pas encore de recrutement
        • Pinnacle Clinical Research, LLC
        • Contact:
      • San Antonio, Texas, États-Unis, 78222
        • Recrutement
        • Pinnacle Clinical Research - San Antonio
        • Contact:
      • Shavano Park, Texas, États-Unis, 78231
        • Pas encore de recrutement
        • Consano Clinical Research
        • Contact:
      • Weslaco, Texas, États-Unis, 78596
        • Pas encore de recrutement
        • Texas Valley Clinical Research
        • Contact:
    • Utah
      • Salt Lake City, Utah, États-Unis, 84117
    • Virginia
      • Newport News, Virginia, États-Unis, 23606
        • Pas encore de recrutement
        • Tidewater Physicians Multispecialty Group
        • Contact:
    • Washington
      • Redmond, Washington, États-Unis, 98052
    • Wisconsin
      • Kenosha, Wisconsin, États-Unis, 53144
        • Pas encore de recrutement
        • Clinical Investigation Specialists, Inc.-Kenosha-69111
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Part A: Placebo
Placebo as an add-on to diet and exercise.
Médicament: Placebo
Placebo
Expérimental: Part A: Low-dose survodutide
Low-dose survodutide as an add-on to diet and exercise.
Médicament: Survodutide
Survodutide
Autres noms:
  • BI456906
Expérimental: Part A: High-dose survodutide
High-dose survodutide as add-on to diet and exercise
Médicament: Survodutide
Survodutide
Autres noms:
  • BI456906
Comparateur placebo: Part B: Placebo
Placebo as an add-on to anti-diabetic drugs.
Médicament: Placebo
Placebo
Expérimental: Part B: Low-dose survodutide
Low-dose survodutide as an add-on to anti-diabetic drugs.
Médicament: Survodutide
Survodutide
Autres noms:
  • BI456906
Expérimental: Part B: High-dose survodutide
High-dose survodutide as an add-on to anti-diabetic drugs.
Médicament: Survodutide
Survodutide
Autres noms:
  • BI456906
Comparateur placebo: Part C: Placebo
Placebo as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Médicament: Placebo
Placebo
Expérimental: Part C: Low-dose survodutide
Low-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Médicament: Survodutide
Survodutide
Autres noms:
  • BI456906
Expérimental: Part C: High-dose survodutide
High-dose as an add-on to basal insulin therapy with or without anti-diabetic drugs.
Médicament: Survodutide
Survodutide
Autres noms:
  • BI456906

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Délai: At baseline and Week 41.
At baseline and Week 41.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Key secondary endpoint: Absolute change in HbA1c (%) from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.
Key secondary endpoint: Achievement of HbA1c <6.5% (yes/no) at Week 41
Délai: At baseline and Week 41.
At baseline and Week 41.
Achievement of HbA1c <5.7% (yes/no) at Week 41
Délai: At Week 41.
At Week 41.
Absolute change in fasting plasma glucose (mg/dL) from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.
Percent change in body weight (kg) from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.
Relative change in non-HDL (high-density lipoprotein) cholesterol from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.
Relative change in triglycerides from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.
Estimated glomerular filtration rate (CKD-EPIcr) slope of change from baseline to Week 53
Délai: At baseline and Week 53.
CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
At baseline and Week 53.
Relative change in urinary albumin-to-creatinine ratio (UACR) from baseline to Week 53 as a continuous variable
Délai: At baseline and Week 53.
At baseline and Week 53.
Absolute change in systolic blood pressure (SBP, mmHg) from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.
Part C: Absolute change in daily basal insulin dose from baseline to Week 53
Délai: At baseline and Week 53.
At baseline and Week 53.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 août 2026

Achèvement primaire (Estimé)

17 janvier 2028

Achèvement de l'étude (Estimé)

1 mai 2028

Dates d'inscription aux études

Première soumission

5 août 2026

Première soumission répondant aux critères de contrôle qualité

5 août 2026

Première publication (Réel)

10 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1404-0115

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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