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

NCT05144984 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: NN9389-4606U1111-1259-27412020-004863-14jRCT2031210474
• Study Type: interventional
• Target: 500
• Locations: 9 countries
• Sites: 129

Brief 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. 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.

  Baseline (week 0), (week 34)

Secondary Outcomes (14)

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline (week 0), (week 34)

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

  Baseline (week 0), (week 34)

• Percent Change From Baseline in Body Weight

  Baseline (week 0), (week 34)

• Change From Baseline in Waist Circumference

  Baseline (week 0), (week 34)

• Change From Baseline in Systolic Blood Pressure (SBP)

  Baseline (week 0), (week 34)

Study Arms (10)

2.4 mg semaglutide + 2.4 mg NNC0480-0389

EXPERIMENTAL

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.

Drug: NNC0480-0389; Drug: Semaglutide

Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)

PLACEBO COMPARATOR

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)

2.4 mg semaglutide + 7.2 mg NNC0480-0389

EXPERIMENTAL

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

Drug: NNC0480-0389; Drug: Semaglutide

2.4 mg semaglutide + 12.0 mg NNC0480-0389

EXPERIMENTAL

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

Drug: NNC0480-0389; Drug: Semaglutide

2.4 mg semaglutide + 21.6 mg NNC0480-0389

EXPERIMENTAL

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide

Drug: NNC0480-0389; Drug: Semaglutide

NNC0480-0389 + placebo (semaglutide)

EXPERIMENTAL

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)

Drug: NNC0480-0389; Drug: Placebo (semaglutide)

Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)

PLACEBO COMPARATOR

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)

Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)

PLACEBO COMPARATOR

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)

Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)

PLACEBO COMPARATOR

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).

Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)

Semaglutide 2.4 mg + placebo (NNC0480-0389)

EXPERIMENTAL

subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.

Drug: Semaglutide; Drug: Placebo (NNC080-0389)

Interventions

NNC0480-0389 DRUG

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

2.4 mg semaglutide + 12.0 mg NNC0480-0389; 2.4 mg semaglutide + 2.4 mg NNC0480-0389; 2.4 mg semaglutide + 21.6 mg NNC0480-0389; 2.4 mg semaglutide + 7.2 mg NNC0480-0389; NNC0480-0389 + placebo (semaglutide)

Semaglutide DRUG

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; 2.4 mg semaglutide + 2.4 mg NNC0480-0389; 2.4 mg semaglutide + 21.6 mg NNC0480-0389; 2.4 mg semaglutide + 7.2 mg NNC0480-0389; Semaglutide 2.4 mg + placebo (NNC0480-0389)

Placebo (NNC080-0389) DRUG

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

Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389); Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389); Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389); Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389); Semaglutide 2.4 mg + placebo (NNC0480-0389)

Placebo (semaglutide) DRUG

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

NNC0480-0389 + placebo (semaglutide); Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389); Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389); Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389); Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (129)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

Location

Synexus Clinical Research

Glendale, Arizona, 85308, United States

Location

University of Arizona/Banner Health

Phoenix, Arizona, 85006, United States

Location

American Clinical Trials

Buena Park, California, 90620, United States

Location

San Fernando Valley Hlth Inst, LLC

Canoga Park, California, 91304, United States

Location

Velocity Clin Res-Chula Vista

Chula Vista, California, 91911, United States

Location

Headlands Research California, LLC

Escondido, California, 92025, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Velocity Clinical Research San Diego

La Mesa, California, 91942, United States

Location

First Valley Med Grp Lancaster

Lancaster, California, 93534, United States

Location

Torrance Clin Res Inst, Inc.

Lomita, California, 90717, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Artemis Insitute for Clin Res

Riverside, California, 92503, United States

Location

Artemis Institute for Clin Res

San Diego, California, 92103, United States

Location

Shahram Jacobs MD Inc.

Sherman Oaks, California, 91403, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Northeast Research Institute

Jacksonville, Florida, 32204, United States

Location

Reyes Clinical Research, Inc

Miami, Florida, 33175, United States

Location

South Broward Research LLC

Miramar, Florida, 33027, United States

Location

Clinical Trial Res Assoc,Inc

Plantation, Florida, 33324, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Headlands Research - Sarasota

Sarasota, Florida, 34243, United States

Location

Appalachian Clinical Res LLC

Adairsville, Georgia, 30103, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Macoupin Research Group

Gillespie, Illinois, 62033, United States

Location

UnityPoint Health-Diabetes Care Center

Peoria, Illinois, 61603, United States

Location

Clin Invest Spec, Inc

Wauconda, Illinois, 60084, United States

Location

Iowa Diabetes & Endo Res Ctr

West Des Moines, Iowa, 50265, United States

Location

Cotton O'Neil Diab & Endo Ctr

Topeka, Kansas, 66606, United States

Location

The Research Group of Lexington LLC

Lexington, Kentucky, 40503, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Centex Studies, Inc._Lake Charles

Lake Charles, Louisiana, 70601, United States

Location

Endo And Metab Cons

Rockville, Maryland, 20852, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States

Location

Arcturus HC PLC Troy Med Res

Troy, Michigan, 48098, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

Mercury Str Med Grp, PLLC

Butte, Montana, 59701, United States

Location

Princeton Endo Assoc

Princeton, New Jersey, 08540, United States

Location

Premier Research Inc.

Trenton, New Jersey, 08611, United States

Location

AMC Community Endocrinology

Albany, New York, 12203, United States

Location

Mid Hudson Med Res-New Windsor

New Windsor, New York, 12553, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Physicians East Endocrinology

Greenville, North Carolina, 27834, United States

Location

Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Albert J Weisbrot

Mason, Ohio, 45040-6815, United States

Location

Advanced Med Res Maumee

Maumee, Ohio, 43537, United States

Location

Intend Research

Norman, Oklahoma, 73069, United States

Location

Essential Medical Research LLC

Tulsa, Oklahoma, 74137, United States

Location

CCT Research

Hatboro, Pennsylvania, 19040, United States

Location

Preferred Primary Care Physicians_Pittsburgh

Pittsburgh, Pennsylvania, 15236, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Juno Research, LLC

Houston, Texas, 77074, United States

Location

Southwest Clinical Trials

Houston, Texas, 77074, United States

Location

Centex Studies

Houston, Texas, 77090, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

VIP Trials_San Antonio

San Antonio, Texas, 78230, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Simcare Medical Research, LLC

Sugar Land, Texas, 77478, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

York Clinical Research LLC

Norfolk, Virginia, 23504, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

Medical centre Zdrave 1 OOD

Kozloduy, 3320, Bulgaria

Location

IPMC - Dr. Elizabeta Dimitrova

Petrich, 2850, Bulgaria

Location

UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

Sofia, 1431, Bulgaria

Location

Medical centre - Doverie AD

Sofia, 1632, Bulgaria

Location

UMHAT Sofiamed EAD

Sofia, 1797, Bulgaria

Location

Prevencia - 2000 - MCOC OOD

Stara Zagora, 6000, Bulgaria

Location

MC Berbatov EOOD, Cherni Drin

Yambol, 8600, Bulgaria

Location

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, 8200, Denmark

Location

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, 2900, Denmark

Location

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, 2650, Denmark

Location

University Hospital of Athens ATTIKON

Athens, Attica, 12462, Greece

Location

Iatriko Psychicou Private Clinic

Athens, 115 25, Greece

Location

"Laiko" General Hospital of Athens

Athens, 11527, Greece

Location

Alexandra General Hospital, Therapeutic Clinic

Athens, 11528, Greece

Location

Iatriko Athinon (Athens Medical Canter)

Athens, 15125, Greece

Location

Iatriko Athinon 'Palaiou Falirou'

Athens, 17562, Greece

Location

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

Thessaloniki, 54645, Greece

Location

"Thermi" Private Hosital

Thessaloniki, 57001, Greece

Location

PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum

Pécs, Baranya Vármegye, 7623, Hungary

Location

Debreceni Egyetem Belgyógyászati Klinika

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház

Békéscsaba, 5600, Hungary

Location

Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

Budapest, 1036, Hungary

Location

SOTE ÁOK I. sz. Belgyógyászati és Onkológiai Klinika

Budapest, 1083, Hungary

Location

Bajcsy-Zsilinszky Kórház

Budapest, 1106, Hungary

Location

MED-TIMA Kft.

Budapest, 1132, Hungary

Location

MH Egészségügyi Központ

Budapest, 1134, Hungary

Location

Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület

Debrecen, 4043, Hungary

Location

Békés Megyei Központi Kórház

Gyula, 5700, Hungary

Location

Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

Location

Vas Vármegyei Markusovszky Egyetemi Oktatókórház

Szombathely, 9700, Hungary

Location

Szent Borbála Kórház

Tatabánya, 2800, Hungary

Location

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

Location

Yoshimura clinic

Kumamoto, 861-8039, Japan

Location

Kansai Electric Power Hospital_Center for Diabetes

Osaka, 553-0003, Japan

Location

Tokyo Center Clinic

Tokyo, 103-0028, Japan

Location

ToCROM Clinic_Internal Medicine

Tokyo, 160-0008, Japan

Location

Higashi-shinjuku clinic

Tokyo, 169-0072, Japan

Location

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, 31-501, Poland

Location

Globe Badania Kliniczne Sp. z o.o.

Kłodzko, 57-300, Poland

Location

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

Lodz, 90-338, Poland

Location

FutureMeds Sp. z o.o. Lodz

Lodz, 91-363, Poland

Location

Diabetica Sp. z o.o.

Nysa, 48-300, Poland

Location

Centrum Medyczne dr Sudnik

Sokółka, 16-100, Poland

Location

Osrodek Badan Klinicznych Clinsante

Torun, 87-100, Poland

Location

Centrum Medyczne AMED Warszawa

Warsaw, 00-215, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Location

FutureMeds Sp. z o.o.

Wroclaw, 50-088, Poland

Location

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

Zabrze, 41-800, Poland

Location

Velocity Nova Sp. z o.o.

Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

Location

Tumen State Medical University

Tyumen, Russia, 625023, Russia

Location

LLC RC Medical

Novosibirsk, 630005, Russia

Location

Penza Regional Clinical Hospital named after N.N. Burdenko

Penza, 440026, Russia

Location

Medinet LLC

Saint Petersburg, 194356, Russia

Location

CHC Zvezdara, Clinical department for endocrinology

Belgrade, 11000, Serbia

Location

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, 11000, Serbia

Location

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

Kragujevac, 34000, Serbia

Location

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr

Kragujevac, 34000, Serbia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 6, 2021
• Study Start: November 29, 2021
• Primary Completion: February 13, 2023
• Study Completion: March 23, 2023
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (8); PL (13); US (71); HU (13); DK (3); RU (4); SE (4); JP (6); BU (7)