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
3 other identifiers
interventional
448
11 countries
119
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Shorter than P25 for phase_2
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedStudy Start
First participant enrolled
August 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2025
CompletedDecember 29, 2025
December 1, 2025
1.2 years
August 5, 2024
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
percent point
From baseline (week 0) to end of treatment (week 36)
Secondary Outcomes (17)
Relative change in body weight
From baseline (week 0) to end of treatment (week 36)
Change in body weight
From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
From baseline (week 0) to end of treatment (week 36)
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
From baseline (week 0) to end of treatment (week 36)
- +12 more secondary outcomes
Study Arms (11)
Placebo subcutaneous
PLACEBO COMPARATORPlacebo for subcutaneous treatment
NNC0487-0111 subcutaneous dose 1
EXPERIMENTALNNC0487-0111 subcutaneous dose 1 treatment
NNC0487-0111 subcutaneous dose 2
EXPERIMENTALNNC0487-0111 subcutaneous dose 2 treatment
NNC0487-0111 subcutaneous dose 3
EXPERIMENTALNNC0487-0111 subcutaneous dose 3 treatment
NNC0487-0111 subcutaneous dose 4
EXPERIMENTALNNC0487-0111 subcutaneous dose 4 treatment
NNC0487-0111 subcutaneous dose 5
EXPERIMENTALNNC0487-0111 subcutaneous dose 5 treatment
NNC0487-0111 subcutaneous dose 6
EXPERIMENTALNNC0487-0111 subcutaneous dose 6 treatment
Placebo oral
PLACEBO COMPARATORPlacebo for oral treatment
NNC0487-0111 oral dose 1
EXPERIMENTALNNC0487-0111 oral dose 1 treatment
NNC0487-0111 oral dose 2
EXPERIMENTALNNC0487-0111 oral dose 2 treatment
NNC0487-0111 oral dose 3
EXPERIMENTALNNC0487-0111 oral dose 3 treatment
Interventions
NNC0487-0111 administered subcutanously (under the skin)
NNC0487-0111 placebo administered subcutanously (under the skin)
NNC0487-0111 administered orally (in the mouth)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (119)
Southern Cal Clinical Research
Santa Ana, California, 92701, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
Fleming Island Ctr for Clin Res
Fleming Island, Florida, 32003, United States
Encore Medical Research LLC
Hollywood, Florida, 33024, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Florida Inst For Clin Res
Orlando, Florida, 32825, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Advanced Internal Medicine, PLLC
Paducah, Kentucky, 42001, United States
Medstar Research Institute_Hyattsville
Hyattsville, Maryland, 20782, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, 48098, United States
Arcturus Healthcare, PLC
Troy, Michigan, 48098, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
Lucas Research Inc.
Morehead City, North Carolina, 28557, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, 58104, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15236, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
MidState Endocrine Associates
Nashville, Tennessee, 37203, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
Victorium Clinical Research
Houston, Texas, 77024, United States
Synergy Groups Medical
Houston, Texas, 77061, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Radiance Clinical Research
Lampasas, Texas, 76550, United States
Tekton Research
McKinney, Texas, 75069, United States
Hillcrest Family Health Center
Waco, Texas, 76708, United States
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
Kyustendil, 2500, Bulgaria
IPSOMC Dr. Miglena Rizova Ltd.
Kyustendil, 2500, Bulgaria
UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
Plovdiv, 4001, Bulgaria
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, 4001, Bulgaria
DCC Sveti Georgi EOOD
Plovdiv, 4002, Bulgaria
Diagnostic-Consultative Centre "Sveti Georgi" Eood
Plovdiv, 4002, Bulgaria
Medical centre Regina Life Clinic EOOD
Sofia, 1000, Bulgaria
UMHAT "Aleksandrovska"
Sofia, 1431, Bulgaria
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, 1431, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, 1431, Bulgaria
AIPSMC Dr. Artin Magardichyan EOOD
Varna, 9020, Bulgaria
Poliklinika Solmed
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Centre Rijeka_Endocrinology
Rijeka, Primorje-Gorski Kotar County, 51 000, Croatia
KBC Rijeka, Endokrinologija
Rijeka, Primorje-Gorski Kotar County, 51 000, Croatia
Opca bolnica Karlovac
Karlovac, 47000, Croatia
Specijalna bolnica Krapinske Toplice - Endokrinologija
Krapinske Toplice, 49217, Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice, 49217, Croatia
Klinicki bolnicki centar Osijek_Endocrinology
Osijek, 31 000, Croatia
Klinicki bolnicki centar Osijek
Osijek, 31 000, Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, 42 000, Croatia
Opca bolnica Varazdin
Varaždin, 42 000, Croatia
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, 22607, Germany
Wendisch/Dahl Hamburg
Hamburg, 22607, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758, Germany
Iatriko Psychicou Private Clinic
Athens, 115 25, Greece
U.G.H of Athens "Attikon"
Athens, 12462, Greece
"Laiko" General Hospital of Athens
Goudi/Athens, 11527, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, 54645, Greece
424 Military General Training Hospital - 2nd Department of Internal Medicine
Thessaloniki, 564 29, Greece
424 Military General Training Hospital
Thessaloniki, 564 29, Greece
"Thermi" Private Hosital
Thessaloniki, 57001, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, GR-54643, Greece
"Thermi" Private Hosital
Thessaloniki, GR-57001, Greece
Debreceni Egyetem
Debrecen, Hajdú-Bihar, 4032, Hungary
Bajcsy-Zsilinszky Kórház
Budapest, 1106, Hungary
MH Egészségügyi Központ
Budapest, 1134, Hungary
Debreceni Egyetem
Debrecen, 4031, Hungary
Debreceni Egyetem
Debrecen, H-4031, Hungary
Debreceni Egyetem
Debrecen, H-4032, Hungary
Békés Megyei Központi Kórház
Gyula, 5700, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, H-7400, Hungary
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, 880-0034, Japan
Heiwadai Hospital
Miyazaki, Miyazaki, 880-0034, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009, Japan
Tokuyama clinic_Diabetic internal medicine
Chiba, 261-0004, Japan
Tokuyama clinic
Chiba, 261-0004, Japan
Akaicho Clinic
Chiba-shi, Chiba, 260-0804, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Naka Kinen Clinic
Ibaraki, 311-0113, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
Fukuwa Clinic
Tokyo, 104-0031, Japan
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261, Poland
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220, Poland
Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220, Poland
EKAMED sp. z o.o.
Lublin, Lublin Voivodeship, 20-718, Poland
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110, Poland
Specderm Poznanska Sp. j.
Bialystok, Podlaskie Voivodeship, 15-375, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Specderm Poznańska Spółka Jawna
Bialystok, 15-375, Poland
EKAMED sp. z o.o.
Lublin, 20-718, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Ruda Śląska, 41-709, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507, Poland
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Łódź Voivodeship, 90-302, Poland
SC Grand Med SRL
Oradea, Bihor County, 410025, Romania
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, 020475, Romania
Spitalul Clinic Judetean Urgenta Cluj-Napoca
Cluj-Napoca, Cluj, 400006, Romania
Sc Mediab Srl
Târgu Mureş, Mureș County, 540142, Romania
Novus Medical Clinica SRL
Ploieşti, Prahova, 100018, Romania
Mariodiab Clinic SRL
Brasov, 500101, Romania
Cabinet Medical Dr Geru SRL
Timișoara, 300288, Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, 300723, Romania
Peter Farkas MD, s.r.o.
Šahy, Slovak Republic, 93601, Slovakia
DENTAVIA s.r.o.
Poprad, 05801, Slovakia
DIABETOL, s.r.o.
Prešov, 080 01, Slovakia
OLIVER - MED s.r.o.
Rimavská Sobota, 979 01, Slovakia
MEDIVASA, s.r.o., Diabetologicka ambulancia
Žilina, 010 01, Slovakia
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
Hospital Infanta Luisa
Seville, 41010, Spain
Hospital Nisa Sevilla Aljarafe
Seville, 41950, Spain
Hospital Vithas Sevilla
Seville, 41950, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 7, 2024
Study Start
August 7, 2024
Primary Completion
October 1, 2025
Study Completion
October 24, 2025
Last Updated
December 29, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com