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Completed

NCT Number: NCT05144984

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical centre Zdrave 1 OOD, Kozloduy, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NNC0480-0389

Drug

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

semaglutide

Drug

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.

Primary outcomes

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c)

    Time frame: Baseline (week 0), (week 34)

    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.

Secondary outcomes

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

  3. Percent Change From Baseline in Body Weight

    Time frame: Baseline (week 0), (week 34)

    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.

  4. Change From Baseline in Waist Circumference

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0), (week 34)

    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.

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

    Time frame: Baseline (week 0) to (week 39)

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2021
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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