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NCT06542874CompletedPhase 2

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
448 (actual)
First submitted
5 Aug 2024
Start date
7 Aug 2024
Primary completion date
1 Oct 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06542874
EU CT number
2023-509412-28-00
EudraCT number
2023-509412-28

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 448
  • From 7 Aug 2024 to the primary completion date, 1 Oct 2025
  • 109 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Other

  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Who the study is looking for

  • Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
  • Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
  • HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
  • Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2.
  • Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (109)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Individual Practice For Specialized Out-Hospital Medical Care Doctor Miglena Rizova Ltd.
Coordinator of this site? Confirm its status
KyustendilBulgariaCompleted
Diagnostic Consultative Center Sveti Georgi EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
Alexandrovska University Hospital
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SofiaBulgariaCompleted
Medical Center Regina Life Clinic Ltd.
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
Ambulatory For Individual Practice And Specialized Medical Aid Dr. Artin Magardichian Ltd.
Coordinator of this site? Confirm its status
VarnaBulgariaCompleted
InnoDiab Forschung Gmbh
Coordinator of this site? Confirm its status
EssenGermanyCompleted
Wendisch/Dahl Hamburg
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HamburgGermanyCompleted
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyCompleted
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Coordinator of this site? Confirm its status
Oldenburg in HolsteinGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
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SevillaSpainCompleted
Hospital Quironsalud Infanta Luisa
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SevillaSpainCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
Athens Medical Center S.A.
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AthensGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
424 Military General Training Hospital
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ThessalonikiGreeceCompleted
Thermi Clinic S.A.
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ThessalonikiGreeceCompleted
Poliklinika Solmed d.o.o.
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Grad ZagrebCroatiaCompleted
Opća bolnica Karlovac
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KarlovacCroatiaCompleted
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
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Krapinske TopliceCroatiaCompleted
Klinički bolnički centar Osijek
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OsijekCroatiaCompleted
Clinical Hospital Centre Rijeka
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RijekaCroatiaCompleted
Opca Bolnica Varazdin
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VarazdinCroatiaCompleted
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
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BudapestHungaryCompleted
Central Hospital Of Northern Pest Military Hospital
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Budapest XIIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
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AichiJapanUnknown status
Tokuyama clinic
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ChibaJapanUnknown status
Tokuyama clinic_Diabetic internal medicine
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ChibaJapanUnknown status
Akaicho Clinic
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Chiba-shi, ChibaJapanUnknown status
Naka Kinen Clinic
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IbarakiJapanUnknown status
Naka Kinen Clinic_Internal medicine
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IbarakiJapanUnknown status
Heiwadai Hospital
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MiyazakiJapanUnknown status
Heiwadai Hospital_Internal Medicine
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MiyazakiJapanUnknown status
Tokyo-Eki Center-building Clinic_Internal Medicine
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TokyoJapanUnknown status
Tokyo-Eki Center-building Clinic
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TokyoJapanUnknown status
Fukuwa Clinic
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TokyoJapanUnknown status
Fukuwa Clinic_Internal Medicine
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TokyoJapanUnknown status
NZOZ Vita-Diabetica Malgorzata Buraczyk
Coordinator of this site? Confirm its status
BialystokPolandCompleted
Specderm Poznanska sp.j.
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BialystokPolandCompleted
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
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CracowPolandCompleted
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
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LegnicaPolandCompleted
Santa SP. z o.o
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LodzPolandCompleted
EKAMED sp. z o.o.
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LublinPolandCompleted
Formed 2 Sp. z o.o.
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OswiecimPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
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Ruda ŚląskaPolandCompleted
Lukmed 2 Sp. z o.o.
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SiedlcePolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandCompleted
Mariodiab Clinic S.R.L.
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BrasovRomaniaCompleted
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
Coordinator of this site? Confirm its status
BucharestRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaCompleted
Grandmed S.R.L.
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OradeaRomaniaCompleted
Novus Medical Clinica S.R.L.
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PloiestiRomaniaCompleted
Mediab S.R.L.
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Târgu MureşRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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TimisoaraRomaniaCompleted
Cabinet Medical Dr Geru S.R.L.
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TimisoaraRomaniaCompleted
Dentavia s.r.o.
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PopradSlovakiaCompleted
DIABETOL, s.r.o.
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PrešovSlovakiaCompleted
OLIVER - MED s.r.o.
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Rimavská SobotaSlovakiaCompleted
Peter Farkas MD, s.r.o.
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ŠahySlovakiaCompleted
Medivasa s.r.o.
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ŽilinaSlovakiaCompleted
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Uni of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Brigham & Women's Hospital
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BostonUnited StatesUnknown status
Clinical Research Professionals
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ChesterfieldUnited StatesUnknown status
Cedar Crosse Research Center
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ChicagoUnited StatesUnknown status
StudyMetrix Research, LLC
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City of Saint PetersUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
Lillestol Research, LLC
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FargoUnited StatesUnknown status
Plains Clinical Research Center, LLC_Fargo
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FargoUnited StatesUnknown status
Fleming Island Ctr for Clin Res
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Fleming IslandUnited StatesUnknown status
Encore Medical Research LLC
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HollywoodUnited StatesUnknown status
Victorium Clinical Research
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HoustonUnited StatesUnknown status
PlanIt Research, PLLC
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HoustonUnited StatesUnknown status
Synergy Groups Medical
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HoustonUnited StatesUnknown status
Medstar Research Institute_Hyattsville
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HyattsvilleUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Radiance Clinical Research
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LampasasUnited StatesUnknown status
Velocity Clin Research LA
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Los AngelesUnited StatesUnknown status
Tekton Research
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McKinneyUnited StatesUnknown status
ActivMed Practice & Research LLC
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MethuenUnited StatesUnknown status
South Broward Research LLC
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MiramarUnited StatesUnknown status
Centricity Rsrch MHCity Multi
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Morehead CityUnited StatesUnknown status
MidState Endocrine Associates
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NashvilleUnited StatesUnknown status
Clinical Research Associates
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NashvilleUnited StatesUnknown status
Alliance for Multispec Res
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NormanUnited StatesUnknown status
Florida Inst For Clin Res
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OrlandoUnited StatesUnknown status
Florida Institute for Clinical Research
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OrlandoUnited StatesUnknown status
MD Medical Research
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Oxon HillUnited StatesUnknown status
Advanced Internal Medicine, PLLC
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PaducahUnited StatesUnknown status
Jefferson Endocrinology Assocs
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PhiladelphiaUnited StatesUnknown status
Preferred Primary Care Physicians - Pittsburgh
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PittsburghUnited StatesUnknown status
Health Concepts
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Rapid CityUnited StatesUnknown status
Southern Cal Clinical Research
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Santa AnaUnited StatesUnknown status
Piedmont Healthcare/Research
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StatesvilleUnited StatesUnknown status
Cotton O'Neil Clinical Research Center
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TopekaUnited StatesUnknown status
Arcturus Healthcare, PLC.
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TroyUnited StatesUnknown status
Arcturus HC PLC Troy Med Res
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TroyUnited StatesUnknown status
Hillcrest Family Health Center
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WacoUnited StatesUnknown status
Chase Medical Research, LLC
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WaterburyUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.