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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: NNC0480-0389; Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide); Drug: Semaglutide

• Registration Number: NCT05144984
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study Start: 2021-11-29
• Study First Posted: 2021-12-06
• Primary Completion: 2023-02-13
• Study Completion: 2023-03-23
• Disposition First Submitted: 2024-02-12
• Disposition First Posted: 2024-02-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0480-0389 + placebo (semaglutide)	NNC0480-0389	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)	Placebo (NNC080-0389)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)	Placebo (semaglutide)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
2.4 mg semaglutide + 7.2 mg NNC0480-0389	NNC0480-0389	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
2.4 mg semaglutide + 12.0 mg NNC0480-0389	NNC0480-0389	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
2.4 mg semaglutide + 21.6 mg NNC0480-0389	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 + placebo (semaglutide)	Placebo (semaglutide)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
2.4 mg semaglutide + 2.4 mg NNC0480-0389	NNC0480-0389	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)	Placebo (NNC080-0389)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)	Placebo (NNC080-0389)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)	Placebo (semaglutide)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)	Placebo (semaglutide)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)	Placebo (NNC080-0389)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)	Placebo (semaglutide)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Semaglutide 2.4 mg + placebo (NNC0480-0389)	Placebo (NNC080-0389)	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
2.4 mg semaglutide + 2.4 mg NNC0480-0389	Semaglutide	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
2.4 mg semaglutide + 7.2 mg NNC0480-0389	Semaglutide	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
2.4 mg semaglutide + 12.0 mg NNC0480-0389	Semaglutide	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
2.4 mg semaglutide + 21.6 mg NNC0480-0389	Semaglutide	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Semaglutide 2.4 mg + placebo (NNC0480-0389)	Semaglutide	subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	From baseline (week 0) to visit 24 (week 34)	percentage-point

Secondary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose (FPG)	From baseline (week 0) to visit 24 (week 34)	measured in mmol/L
Change in body weight (kg)	From baseline (week 0) to visit 24 (week 34)	measured in kg
Relative change in low-density lipoprotein (LDL) cholesterol	From baseline (week 0) to visit 24 (week 34)	ratio
Relative change in triglycerides	From baseline (week 0) to visit 24 (week 34)	ratio
Change in body weight (%)	From baseline (week 0) to visit 24 (week 34)	measured in percent
Change in waist circumference	From baseline (week 0) to visit 24 (week 34)	measured in cm
Change in systolic blood pressure (SBP)	From baseline (week 0) to visit 24 (week 34)	measured in mmHg
Relative change in total cholesterol	From baseline (week 0) to visit 24 (week 34)	ratio
Relative change in high-density lipoprotein (HDL) cholesterol	From baseline (week 0) to visit 24 (week 34)	ratio
Relative change in very-low-density lipoprotein (VLDL) cholesterol	From baseline (week 0) to visit 24 (week 34)	ratio
Relative change in Apolipoprotein B (ApoB)	From baseline (week 0) to visit 24 (week 34)	ratio
Relative change in high sensitivity C-Reactive Protein (hsCRP)	From baseline (week 0) to visit 24 (week 34)	ratio
Relative change in free fatty acids	From baseline (week 0) to visit 24 (week 34)	ratio
Number of treatment-emergent adverse events (TEAEs)	From baseline (week 0) to visit 25 (week 39)	Count of events

Trial Locations

Locations (89)

Kaposi Mór Oktató Kórház; 🇭🇺 Kaposvár, Hungary

Markusovszky Egyetemi Oktatókórház; 🇭🇺 Szombathely, Hungary

Szent Borbála Kórház; 🇭🇺 Tatabánya, Hungary

Naka Kinen Clinic; 🇯🇵 Ibaraki, Japan

Yoshimura clinic; 🇯🇵 Kumamoto, Japan

Kansai Electric Power Hospital; 🇯🇵 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

Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.; 🇵🇱 Lodz, Poland

FutureMeds Sp. z o.o. Lodz; 🇵🇱 Lodz, Poland

Velocity Nova Sp. z o.o.; 🇵🇱 Staszow, Poland

Osrodek Badan Klinicznych Clinsante; 🇵🇱 Torun, Poland

Centrum Medyczne AMED Warszawa; 🇵🇱 Warszawa, Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji; 🇵🇱 Warszawa, Poland

FutureMeds Sp. z o.o.; 🇵🇱 Wroclaw, Poland

MED-TIMA Kft.; 🇭🇺 Budapest, Hungary

MH Egészségügyi Központ; 🇭🇺 Budapest, Hungary

Velocity Clin Res-Chula Vista; 🇺🇸 Chula Vista, California, United States

Headlands Research California, LLC; 🇺🇸 Escondido, California, United States

St. Jos Heritage Hlthcr_Fllrtn; 🇺🇸 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 Wstlke; 🇺🇸 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

San Fernando Valley Hlth Inst; 🇺🇸 West Hills, 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

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Headlands Research - Sarasota; 🇺🇸 Sarasota, Florida, United States

Solaris Clinical Research; 🇺🇸 Meridian, Idaho, United States

Cedar-Crosse Research Center; 🇺🇸 Chicago, Illinois, United States

Iowa Diabetes & Endo Res Ctr; 🇺🇸 West Des Moines, Iowa, United States

The Research Group of Lexington LLC; 🇺🇸 Lexington, Kentucky, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Arcturus Healthcare, PLC; 🇺🇸 Troy, Michigan, United States

Mercury Str Med Grp, PLLC; 🇺🇸 Butte, Montana, United States

Albany Medical College - Endo; 🇺🇸 Albany, 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

Advanced Med Res Maumee; 🇺🇸 Maumee, Ohio, United States

Essential Medical Research LLC; 🇺🇸 Tulsa, Oklahoma, United States

Spartanburg Medical Research; 🇺🇸 Spartanburg, South Carolina, United States

Velocity Clinical Res-Dallas; 🇺🇸 Dallas, Texas, United States

UT Southwestern Med Cntr; 🇺🇸 Dallas, 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

Medical centre "Zdrave 1" OOD; 🇧🇬 Kozloduy, Bulgaria

Individual Practice for medical care -Dr Elizabeta Dimitrova; 🇧🇬 Petrich, Bulgaria

UMHAT Aleksandrovska; 🇧🇬 Sofia, Bulgaria

Medical centre - Doverie AD; 🇧🇬 Sofia, Bulgaria

UMHAT Sofiamed; 🇧🇬 Sofia, Bulgaria

"Prevencia-2000-MCOC"; 🇧🇬 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

Alexandra General Hospital, Therapeutic Clinic; 🇬🇷 Athens, Greece

Iatriko Athinon (Athens Medical Canter); 🇬🇷 Athens, Greece

Iatriko Athinon 'Palaiou Falirou'; 🇬🇷 Athens, Greece

"Laiko" General Hospital of Athens; 🇬🇷 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, Hajdu-Bihar, Hungary

Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.; 🇭🇺 Budapest, Hungary

Bajcsy-Zsilinszky Kórház; 🇭🇺 Budapest, Hungary

Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház; 🇭🇺 Békéscsaba, Hungary

Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület; 🇭🇺 Debrecen, Hungary

Békés Megyei Központi Kórház; 🇭🇺 Gyula, Hungary

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

Tumen State Medical University; 🇷🇺 Tumen, Russia, Russian Federation

LLC RC Medical; 🇷🇺 Novosibirsk, Russian Federation

Penza Regional Clinical Hospital named after N.N. Burdenko; 🇷🇺 Penza, Russian Federation

Medinet LLC; 🇷🇺 Saint-Petersburg, Russian Federation

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