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AzTrials

Diabetes Mellitus, Type 2Phase 2NCT05144984

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

A Phase 2 study testing NNC0480-0389 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 129 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
NNC0480-0389 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
129 sitesin 9 countries
Study dates
29 Nov 2021to 23 Mar 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
  • 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

Who cannot join

  • 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 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
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)

Trial locations and contacts

129 sites in 9 countries.

129 sites in 9 countries

United States71 sites

  • Appalachian Clinical Res LLC

    Adairsville, Georgia, 30103

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Pinnacle Research Group LLC

    Anniston, Alabama, 36207

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-5804

  • American Clinical Trials

    Buena Park, California, 90620

  • Mercury Str Med Grp, PLLC

    Butte, Montana, 59701

  • San Fernando Valley Hlth Inst, LLC

    Canoga Park, California, 91304

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Valley Research

    Fresno, California, 93720

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Macoupin Research Group

    Gillespie, Illinois, 62033

  • Synexus Clinical Research

    Glendale, Arizona, 85308

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • Physicians East Endocrinology

    Greenville, North Carolina, 27834

  • CCT Research

    Hatboro, Pennsylvania, 19040

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Juno Research, LLC

    Houston, Texas, 77074

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Centex Studies

    Houston, Texas, 77090

  • Northeast Research Institute

    Jacksonville, Florida, 32204

  • Velocity Clinical Research San Diego

    La Mesa, California, 91942

  • Centex Studies, Inc._Lake Charles

    Lake Charles, Louisiana, 70601

  • First Valley Med Grp Lancaster

    Lancaster, California, 93534

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Albert J Weisbrot

    Mason, Ohio, 45040-6815

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Mid Hudson Med Res-New Windsor

    New Windsor, New York, 12553

  • York Clinical Research LLC

    Norfolk, Virginia, 23504

  • Intend Research

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • UnityPoint Health-Diabetes Care Center

    Peoria, Illinois, 61603

  • University of Arizona/Banner Health

    Phoenix, Arizona, 85006

  • Preferred Primary Care Physicians_Pittsburgh

    Pittsburgh, Pennsylvania, 15236

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida, 33324

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Princeton Endo Assoc

    Princeton, New Jersey, 08540

  • Artemis Insitute for Clin Res

    Riverside, California, 92503

  • Endo And Metab Cons

    Rockville, Maryland, 20852

  • Quality Research Inc

    San Antonio, Texas, 78209

  • VIP Trials_San Antonio

    San Antonio, Texas, 78230

  • Artemis Institute for Clin Res

    San Diego, California, 92103

  • Headlands Research - Sarasota

    Sarasota, Florida, 34243

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Shahram Jacobs MD Inc.

    Sherman Oaks, California, 91403

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Simcare Medical Research, LLC

    Sugar Land, Texas, 77478

  • Cotton O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Premier Research Inc.

    Trenton, New Jersey, 08611

  • Arcturus HC PLC Troy Med Res

    Troy, Michigan, 48098

  • Essential Medical Research LLC

    Tulsa, Oklahoma, 74137

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Clin Invest Spec, Inc

    Wauconda, Illinois, 60084

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50265

Other trials in United States

Hungary13 sites

  • Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház

    Békéscsaba, 5600

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1036

  • SOTE ÁOK I. sz. Belgyógyászati és Onkológiai Klinika

    Budapest, 1083

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106

  • MED-TIMA Kft.

    Budapest, 1132

  • MH Egészségügyi Központ

    Budapest, 1134

  • Debreceni Egyetem Belgyógyászati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület

    Debrecen, 4043

  • Békés Megyei Központi Kórház

    Gyula, 5700

  • Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum

    Pécs, Baranya Vármegye, 7623

  • Vas Vármegyei Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

  • Szent Borbála Kórház

    Tatabánya, 2800

Other trials in Hungary

Poland13 sites

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879

  • Globe Badania Kliniczne Sp. z o.o.

    Kłodzko, 57-300

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-338

  • FutureMeds Sp. z o.o. Lodz

    Lodz, 91-363

  • Diabetica Sp. z o.o.

    Nysa, 48-300

  • Centrum Medyczne dr Sudnik

    Sokółka, 16-100

  • Velocity Nova Sp. z o.o.

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • Osrodek Badan Klinicznych Clinsante

    Torun, 87-100

  • Centrum Medyczne AMED Warszawa

    Warsaw, 00-215

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

  • FutureMeds Sp. z o.o.

    Wroclaw, 50-088

  • SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze

    Zabrze, 41-800

Other trials in Poland

Greece8 sites

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • Iatriko Psychicou Private Clinic

    Athens, 115 25

  • "Laiko" General Hospital of Athens

    Athens, 11527

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, 11528

  • Iatriko Athinon (Athens Medical Canter)

    Athens, 15125

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562

  • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

    Thessaloniki, 54645

  • "Thermi" Private Hosital

    Thessaloniki, 57001

Other trials in Greece

Bulgaria7 sites

  • Medical centre Zdrave 1 OOD

    Kozloduy, 3320

  • IPMC - Dr. Elizabeta Dimitrova

    Petrich, 2850

  • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

    Sofia, 1431

  • Medical centre - Doverie AD

    Sofia, 1632

  • UMHAT Sofiamed EAD

    Sofia, 1797

  • Prevencia - 2000 - MCOC OOD

    Stara Zagora, 6000

  • MC Berbatov EOOD, Cherni Drin

    Yambol, 8600

Other trials in Bulgaria

Japan6 sites

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Yoshimura clinic

    Kumamoto, 861-8039

  • Kansai Electric Power Hospital_Center for Diabetes

    Osaka, 553-0003

  • Tokyo Center Clinic

    Tokyo, 103-0028

  • ToCROM Clinic_Internal Medicine

    Tokyo, 160-0008

  • Higashi-shinjuku clinic

    Tokyo, 169-0072

Other trials in Japan

Russia4 sites

  • LLC RC Medical

    Novosibirsk, 630005

  • Penza Regional Clinical Hospital named after N.N. Burdenko

    Penza, 440026

  • Medinet LLC

    Saint Petersburg, 194356

  • Tumen State Medical University

    Tyumen, Russia, 625023

Other trials in Russia

Serbia4 sites

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr

    Kragujevac, 34000

Other trials in Serbia

Denmark3 sites

  • Aarhus Universitetshospital Diabetes og Hormonsygdomme

    Aarhus N, 8200

  • Gentofte Hospital - Center for Klinisk Metabolisk Forskning

    Hellerup, 2900

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.

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.

Read more

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

Being tested
NNC0480-0389, Semaglutide, Placebo (NNC080-0389), Placebo (semaglutide)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0480-0389Drug

    A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.

  • SemaglutideDrug

    A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.

  • Placebo (NNC080-0389)Drug

    A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.

  • Placebo (semaglutide)Drug

    A weekly dose of placebo (semaglutide). The study will last for about 41weeks.

Study groups in NCT05144984
Study groupRoleWhat they receive
2.4 mg semaglutide + 2.4 mg NNC0480-0389Experimentalsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
Receives: Drug: NNC0480-0389; Drug: Semaglutide
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)Placebo comparatorsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Receives: Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)
2.4 mg semaglutide + 7.2 mg NNC0480-0389Experimentalsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Receives: Drug: NNC0480-0389; Drug: Semaglutide
2.4 mg semaglutide + 12.0 mg NNC0480-0389Experimentalsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Receives: Drug: NNC0480-0389; Drug: Semaglutide
2.4 mg semaglutide + 21.6 mg NNC0480-0389Experimentalsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Receives: Drug: NNC0480-0389; Drug: Semaglutide
NNC0480-0389 + placebo (semaglutide)Experimentalsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
Receives: Drug: NNC0480-0389; Drug: Placebo (semaglutide)
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)Placebo comparatorsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Receives: Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)Placebo comparatorsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Receives: Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)Placebo comparatorsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Receives: Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)
Semaglutide 2.4 mg + placebo (NNC0480-0389)Experimentalsubjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
Receives: Drug: Semaglutide; Drug: Placebo (NNC080-0389)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c)

    Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

Secondary outcomes (14)

  1. Change From Baseline in Fasting Plasma Glucose (FPG)

    Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  2. Change From Baseline in Body Weight (Kilogram [kg])

    Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  3. Percent Change From Baseline in Body Weight

    Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  4. Change From Baseline in Waist Circumference

    Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  5. Change From Baseline in Systolic Blood Pressure (SBP)

    Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  6. Relative Change From Baseline in Total Cholesterol - Ratio to Baseline

    Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  7. Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

    Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  8. Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

    Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  9. Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline

    Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  10. Relative Change From Baseline in Triglycerides - Ratio to Baseline

    Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  11. Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline

    Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  12. Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline

    Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  13. Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

    Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.

    Measured: Baseline (week 0), (week 34)

  14. Number of Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.

    Measured: Baseline (week 0) to (week 39)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start29 Nov 2021
  3. Primary completion13 Feb 2023
  4. Study completion23 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05144984
Sponsor's protocol ID
NN9389-4606
Other IDs
U1111-1259-2741, 2020-004863-14, jRCT2031210474
Status last verified
Mar 2026
First submitted
22 Nov 2021
Last updated
9 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0480-0389 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 129 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Hungary, Poland, Greece, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Baseline (week 0), (week 34)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05144984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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Clinical Trial NCT05144984 | AzTrials