A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
NCT ID: NCT05144984
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
500 participants
INTERVENTIONAL
2021-11-29
2023-03-23
Brief Summary
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The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.
Participants will either get:
Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).
NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.
Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.
Participant must inject the study medicines themself into the stomach, thigh, or upper arm.
The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.
Women can only take part in the study if they are not able to become pregnant
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2.4 mg semaglutide + 21.6 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
NNC0480-0389 + placebo (semaglutide)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Semaglutide 2.4 mg + placebo (NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
2.4 mg semaglutide + 2.4 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
2.4 mg semaglutide + 7.2 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
2.4 mg semaglutide + 12.0 mg NNC0480-0389
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Interventions
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NNC0480-0389
A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.
Semaglutide
A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Placebo (NNC080-0389)
A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.
Placebo (semaglutide)
A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Eligibility Criteria
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Inclusion Criteria
* Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
* BMI greater than or equal to 25 and below 40 kg/m\^2
* 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
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Pinnacle Research Group LLC
Anniston, Alabama, United States
Synexus Clinical Research
Glendale, Arizona, United States
University of Arizona/Banner Health
Phoenix, Arizona, United States
American Clinical Trials
Buena Park, California, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
Headlands Research California, LLC
Escondido, California, United States
Valley Research
Fresno, California, United States
Providence Medical Foundation
Fullerton, California, United States
Velocity Clinical Research San Diego
La Mesa, California, United States
First Valley Med Grp Lancaster
Lancaster, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Artemis Insitute for Clin Res
Riverside, California, United States
Artemis Institute for Clin Res
San Diego, California, United States
Shahram Jacobs MD Inc.
Sherman Oaks, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Northeast Research Institute
Jacksonville, Florida, United States
Reyes Clinical Research, Inc
Miami, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Headlands Research - Sarasota
Sarasota, Florida, United States
Appalachian Clinical Res LLC
Adairsville, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Macoupin Research Group
Gillespie, Illinois, United States
UnityPoint Health-Diabetes Care Center
Peoria, Illinois, United States
Clin Invest Spec, Inc
Wauconda, Illinois, United States
Iowa Diabetes & Endo Res Ctr
West Des Moines, Iowa, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
The Research Group of Lexington LLC
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Centex Studies, Inc._Lake Charles
Lake Charles, Louisiana, United States
Endo And Metab Cons
Rockville, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Mercury Str Med Grp, PLLC
Butte, Montana, United States
Princeton Endo Assoc
Princeton, New Jersey, United States
Premier Research Inc.
Trenton, New Jersey, United States
AMC Community Endocrinology
Albany, New York, United States
Mid Hudson Med Res-New Windsor
New Windsor, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Physicians East Endocrinology
Greenville, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Albert J Weisbrot
Mason, Ohio, United States
Advanced Med Res Maumee
Maumee, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Essential Medical Research LLC
Tulsa, Oklahoma, United States
CCT Research
Hatboro, Pennsylvania, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Centex Studies
Houston, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
VIP Trials_San Antonio
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
York Clinical Research LLC
Norfolk, Virginia, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
Medical centre Zdrave 1 OOD
Kozloduy, , Bulgaria
IPMC - Dr. Elizabeta Dimitrova
Petrich, , Bulgaria
UMHAT Aleksandrovska
Sofia, , Bulgaria
Medical centre - Doverie AD
Sofia, , Bulgaria
UMHAT Sofiamed EAD
Sofia, , Bulgaria
Prevencia - 2000 - MCOC OOD
Stara Zagora, , Bulgaria
Medical center Berbatov
Yambol, , Bulgaria
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N, , Denmark
Center for Klinisk Metabolisk Forskning
Hellerup, , Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, , Denmark
University Hospital of Athens ATTIKON
Athens, Attica, Greece
Iatriko Psychicou Private Clinic
Athens, , Greece
"Laiko" General Hospital of Athens
Athens, , Greece
Alexandra General Hospital, Therapeutic Clinic
Athens, , Greece
Iatriko Athinon (Athens Medical Canter)
Athens, , Greece
Iatriko Athinon 'Palaiou Falirou'
Athens, , Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, , Greece
"Thermi" Private Hosital
Thessaloniki, , Greece
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
Pécs, Baranya Vármegye, Hungary
Debreceni Egyetem Belgyógyászati Klinika
Debrecen, Hajdú-Bihar, Hungary
Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház
Békéscsaba, , Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, , Hungary
SOTE ÁOK I. sz. Belgyógyászati és Onkológiai Klinika
Budapest, , Hungary
Bajcsy-Zsilinszky Kórház
Budapest, , Hungary
MED-TIMA Kft.
Budapest, , Hungary
MH Egészségügyi Központ
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület
Debrecen, , Hungary
Békés Megyei Központi Kórház
Gyula, , Hungary
Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Szent Borbála Kórház
Tatabánya, , Hungary
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Yoshimura clinic
Kumamoto, , Japan
Kansai Electric Power Hospital_Center for Diabetes
Osaka, , Japan
Tokyo Center Clinic
Tokyo, , Japan
ToCROM Clinic
Tokyo, , Japan
Higashi-shinjuku clinic
Tokyo, , Japan
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Globe Badania Kliniczne Sp. z o.o.
Kłodzko, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
FutureMeds Sp. z o.o. Lodz
Lodz, , Poland
Diabetica Sp. z o.o.
Nysa, , Poland
Centrum Medyczne dr Sudnik
Sokółka, , Poland
Osrodek Badan Klinicznych Clinsante
Torun, , Poland
Centrum Medyczne AMED Warszawa
Warsaw, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, , Poland
FutureMeds Sp. z o.o.
Wroclaw, , Poland
SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze
Zabrze, , Poland
Velocity Nova Sp. z o.o.
Staszów, Świętokrzyskie Voivodeship, Poland
Tumen State Medical University
Tyumen, Russia, Russia
LLC RC Medical
Novosibirsk, , Russia
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, , Russia
Medinet LLC
Saint Petersburg, , Russia
CHC Zvezdara, Clinical department for endocrinology
Belgrade, , Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, , Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, , Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr
Kragujevac, , Serbia
Countries
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Other Identifiers
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U1111-1259-2741
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004863-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2031210474
Identifier Type: OTHER
Identifier Source: secondary_id
NN9389-4606
Identifier Type: -
Identifier Source: org_study_id
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