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

28 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

600

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Australië
    • New South Wales
      • Camperdown, New South Wales, Australië, 2050
    • Queensland
      • Meadowbrook, Queensland, Australië, 4131
    • South Australia
      • Oaklands Park, South Australia, Australië, 5046
        • Werving
        • Southern Adelaide Diabetes & Endocrine services
        • Contact:
    • Victoria
      • Melbourne, Victoria, Australië, 3004
        • Nog niet aan het werven
        • Baker Heart and Diabetes Institute
        • Contact:
  • Canada
      • Québec, Canada, G1G 5X1
        • Werving
        • Recherche Clinique Sigma Inc.
        • Contact:
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Werving
        • Centricity Research (Brampton)
        • Contact:
      • Concord, Ontario, Canada, L4K 4M2
        • Werving
        • Centricity Research (Vaughan)
        • Contact:
      • Nepean, Ontario, Canada, K2J 0V2
        • Werving
        • Centricity Research (Nepean)
        • Contact:
      • Toronto, Ontario, Canada, M6G 1M2
        • Werving
        • Diabetes Heart Research Centre
        • Contact:
      • Toronto, Ontario, Canada, M4G 3E8
        • Werving
        • Centricity Research (Bayview)
        • Contact:
      • Toronto, Ontario, Canada, M9V 4B4
        • Werving
        • Albion Finch Medical Centre
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Werving
        • Applied Medical Informatics Research Inc.
        • Contact:
      • Montreal, Quebec, Canada, H4J 1E3
        • Werving
        • Endocrinologie Oasis Inc
        • Contact:
  • Indië
      • Ahmedabad, Indië, 380006
        • Nog niet aan het werven
        • Gujarat Endocrine Centre
        • Contact:
      • Ahmedabad, Indië, 380006
        • Nog niet aan het werven
        • Sardar Vallabhbhai Patel Institute of Medical Sciences and Research
        • Contact:
      • Bhubaneswar, Indië, 751019
        • Nog niet aan het werven
        • AIIMS Bhubaneshwar
        • Contact:
      • Cuttack, Indië, 753007
        • Nog niet aan het werven
        • S.C.B. Medical College & Hospital
        • Contact:
      • Hyderabad, Afzalgunj, Indië, 500012
        • Nog niet aan het werven
        • Osmania Medical College & Hospital
        • Contact:
      • Kolhāpur, Indië, 416003
        • Nog niet aan het werven
        • Shree Mahalaxmi Diatone Institute
        • Contact:
      • Lucknow, Indië, 226 014
        • Nog niet aan het werven
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Contact:
      • Nagpur, Indië, 440010
        • Nog niet aan het werven
        • Diabetes Care and Research Centre
        • Contact:
      • Nashik, Indië, 422002
        • Nog niet aan het werven
        • Supe Heart & Diabetes Hospital & Research Centre
        • Contact:
      • New Delhi, Indië, 110029
        • Nog niet aan het werven
        • AIIMS, New Delhi
        • Contact:
      • Pune, Indië, 411004
        • Nog niet aan het werven
        • Deenanath Mangeshkar Hospital and Research Centre
        • Contact:
      • Trivandrum, Indië, 695032
        • Nog niet aan het werven
        • Jothydev's Diabetes Research Centre
        • Contact:
      • Visakhapatnam, Indië, 530040
        • Nog niet aan het werven
        • Vishakha Institute of Medical Sciences
        • Contact:
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland, 0626
      • Hamilton, Nieuw-Zeeland, 3204
    • Dunedin
      • Central Dunedin, Dunedin, Nieuw-Zeeland, 9016
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35235
        • Geschorst
        • Cahaba Research, Inc. - Trussville Location
    • Arizona
      • Gilbert, Arizona, Verenigde Staten, 85296
        • Nog niet aan het werven
        • Mission Research Institute - Gilbert
        • Contact:
      • Paradise Valley, Arizona, Verenigde Staten, 85253
        • Geschorst
        • Helios Clinical Research - Paradise Valley
      • Phoenix, Arizona, Verenigde Staten, 85028
        • Geschorst
        • Helios Clinical Research - Phoenix
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72211
        • Geschorst
        • Woodland International Research Group, Inc.
    • California
      • Canoga Park, California, Verenigde Staten, 91304
      • Concord, California, Verenigde Staten, 94520
        • Geschorst
        • John Muir Physician Network Clinical Research Center
      • Escondido, California, Verenigde Staten, 92025
        • Geschorst
        • Neighborhood Healthcare - Escondido
      • Lincoln, California, Verenigde Staten, 95648
        • Geschorst
        • Clinical Trials Research - Lincoln
      • Long Beach, California, Verenigde Staten, 90815
        • Geschorst
        • ARK Clinical Research
      • Northridge, California, Verenigde Staten, 91325
        • Geschorst
        • Valley Clinical Trials, Inc.
      • Spring Valley, California, Verenigde Staten, 91978
        • Geschorst
        • Encompass Clinical Research, Spring Valley
      • Walnut Creek, California, Verenigde Staten, 94598
        • Geschorst
        • Diablo Clinical Research
      • West Hills, California, Verenigde Staten, 91307
        • Geschorst
        • Focus Clinical Research
    • Florida
      • Clearwater, Florida, Verenigde Staten, 33765
        • Geschorst
        • Clinical Research of West Florida, Inc.
      • Fort Myers, Florida, Verenigde Staten, 33912
        • Geschorst
        • Covenant Metabolic Specialists, LLC - Fort Myers
      • Hollywood, Florida, Verenigde Staten, 33024
        • Geschorst
        • Encore Medical Research
      • Lakeland, Florida, Verenigde Staten, 33803
        • Geschorst
        • Accel Research Sites - Lakeland
      • Lakeland, Florida, Verenigde Staten, 33805
        • Geschorst
        • Clinical Research of Central Florida - Lakeland
      • Largo, Florida, Verenigde Staten, 33777
        • Geschorst
        • Tampa Bay Medical Research - Largo
      • Miami, Florida, Verenigde Staten, 33165
        • Geschorst
        • New Horizon Research Center-Miami-69732
      • Riverview, Florida, Verenigde Staten, 33578
        • Geschorst
        • Covenant Metabolic Specialists, LLC - Brandon
      • University Park, Florida, Verenigde Staten, 34201
        • Geschorst
        • Covenant Metabolic Specialists, LLC - Sarasota
      • Weston, Florida, Verenigde Staten, 33331
        • Geschorst
        • Encore Medical Research - Weston
      • Winter Park, Florida, Verenigde Staten, 32789
        • Geschorst
        • Conquest Research
    • Georgia
      • Columbus, Georgia, Verenigde Staten, 31904
        • Geschorst
        • Centricity Research, Endocrine Consultants
      • Fayetteville, Georgia, Verenigde Staten, 30214
        • Geschorst
        • Javara-Fayetteville-67354
      • Lawrenceville, Georgia, Verenigde Staten, 30046
        • Nog niet aan het werven
        • Balanced Life Health Care Solutions
        • Contact:
      • Union City, Georgia, Verenigde Staten, 30291
        • Nog niet aan het werven
        • Rophe Adult and Pediatric Medicine
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96817
        • Nog niet aan het werven
        • Pacific Diabetes & Endocrine Center
        • Contact:
    • Idaho
      • Blackfoot, Idaho, Verenigde Staten, 83221
        • Geschorst
        • Elite Clinical Trials - Blackfoot
      • Idaho Falls, Idaho, Verenigde Staten, 83404
        • Nog niet aan het werven
        • Family First Clinical Research
        • Contact:
      • Meridian, Idaho, Verenigde Staten, 83646
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40509
        • Geschorst
        • AMR Lexington
    • Maryland
      • Rockville, Maryland, Verenigde Staten, 20852
        • Nog niet aan het werven
        • Endocrine and Metabolic Consultants
        • Contact:
    • Michigan
      • Buckley, Michigan, Verenigde Staten, 49620
        • Nog niet aan het werven
        • Northern Pines Health Center - Buckley
        • Contact:
      • Dearborn, Michigan, Verenigde Staten, 48126
        • Geschorst
        • Revival Research Institute, LLC - Dearborn
      • Troy, Michigan, Verenigde Staten, 48098
        • Geschorst
        • Arcturus Healthcare - Troy Internal Medicine Research Division
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55416
    • Mississippi
      • Olive Branch, Mississippi, Verenigde Staten, 38654
        • Geschorst
        • Olive Branch Family Medical Center
    • Montana
      • Kalispell, Montana, Verenigde Staten, 59901
        • Nog niet aan het werven
        • Logan Health Research - Kalispell
        • Contact:
      • Missoula, Montana, Verenigde Staten, 59804
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89128
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87102
    • New York
      • Brooklyn, New York, Verenigde Staten, 11215
        • Geschorst
        • Ellipsis Research Group - Brooklyn
    • North Carolina
      • Fayetteville, North Carolina, Verenigde Staten, 28304
        • Geschorst
        • Javara Inc. - Cape Fear Valley Medical Center
      • Greensboro, North Carolina, Verenigde Staten, 27408
        • Geschorst
        • PharmQuest Life Sciences
      • Morehead City, North Carolina, Verenigde Staten, 28557
        • Geschorst
        • Centricity Research - Morehead City
    • Ohio
      • Canton, Ohio, Verenigde Staten, 44718
        • Geschorst
        • Diabetes & Endocrinology Associates of Stark County
      • Maumee, Ohio, Verenigde Staten, 43537
        • Geschorst
        • Advanced Medical Research - Maumee
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73134
        • Geschorst
        • Tekton Research Oklahoma City
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15236
        • Geschorst
        • Preferred Primary Care Physicians-Pittsburgh-63932
      • Uniontown, Pennsylvania, Verenigde Staten, 15401
        • Geschorst
        • Preferred Primary Care Physicians - Matthew Drive
    • South Carolina
      • Bluffton, South Carolina, Verenigde Staten, 29910
        • Nog niet aan het werven
        • PanAmerican Clinical Research - Bluffton
        • Contact:
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • Voltooid
        • Spartanburg Medical Research
    • Tennessee
      • Chattanooga, Tennessee, Verenigde Staten, 37411
        • Geschorst
        • University Diabetes & Endocrine Consultants
      • Memphis, Tennessee, Verenigde Staten, 38115
    • Texas
      • Austin, Texas, Verenigde Staten, 78731
        • Geschorst
        • Texas Diabetes and Endocrinology - Central Austin
      • Brownsville, Texas, Verenigde Staten, 78520
        • Geschorst
        • South Texas Research Institute - Brownsville
      • Conroe, Texas, Verenigde Staten, 77384
        • Geschorst
        • Privia Medical Group Gulf Coast, PLLC
      • Dallas, Texas, Verenigde Staten, 75390-8837
        • Nog niet aan het werven
        • University of Texas Southwestern Medical Center
        • Contact:
      • Georgetown, Texas, Verenigde Staten, 78626
        • Geschorst
        • Pinnacle Clinical Research - Georgetown
      • Houston, Texas, Verenigde Staten, 77089
      • Houston, Texas, Verenigde Staten, 77084
        • Geschorst
        • Biopharma Informatic, Inc. Research Center
      • Mesquite, Texas, Verenigde Staten, 75149
        • Nog niet aan het werven
        • Southern Endocrinology Associates
        • Contact:
      • San Antonio, Texas, Verenigde Staten, 78222
        • Geschorst
        • Pinnacle Clinical Research - San Antonio
      • San Antonio, Texas, Verenigde Staten, 78229
        • Geschorst
        • Pinnacle Clinical Research, LLC
      • Shavano Park, Texas, Verenigde Staten, 78231
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84117
        • Geschorst
        • Olympus Family Medicine
    • Virginia
      • Newport News, Virginia, Verenigde Staten, 23606
        • Nog niet aan het werven
        • Tidewater Physicians Multispecialty Group
        • Contact:
    • Washington
      • Redmond, Washington, Verenigde Staten, 98052
        • Geschorst
        • ERA Health Research - Redmond

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Part A: Placebo

Placebo as an add-on to diet and exercise.
Geneesmiddel: Placebo

Placebo
Experimenteel: Part A: Low-dose survodutide

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

Survodutide

Andere namen:
  • BI-456906
Experimenteel: Part A: High-dose survodutide

High-dose survodutide as add-on to diet and exercise
Geneesmiddel: Survodutide

Survodutide

Andere namen:
  • BI-456906
Placebo-vergelijker: Part B: Placebo

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

Placebo
Experimenteel: Part B: Low-dose survodutide

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

Survodutide

Andere namen:
  • BI-456906
Experimenteel: Part B: High-dose survodutide

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

Survodutide

Andere namen:
  • BI-456906
Placebo-vergelijker: Part C: Placebo

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

Placebo
Experimenteel: Part C: Low-dose survodutide

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

Survodutide

Andere namen:
  • BI-456906
Experimenteel: Part C: High-dose survodutide

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

Survodutide

Andere namen:
  • BI-456906

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41
Tijdsspanne: At baseline and Week 41.
At baseline and Week 41.

Secundaire uitkomstmaten

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

CKD-EPIcr: Chronic Kidney Disease Epidemiology Collaboration creatinine equation
At baseline and Week 53.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boehringer Ingelheim

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 augustus 2026

Primaire voltooiing (Geschat)

17 januari 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1404-0115

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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