A research study looking at how well a combination of the medicines semaglutide and NNC0480-0389 works in people with type 2 diabetes

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004863-14-GR

Enrollment

495

Registered

2021-07-22

Start date

2021-09-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: NNC0480-0389 A 10 mg/mL Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: *MASKED* Other descriptive name: NNC0480-0389 Concentration unit: mg/ml milligram

Eligibility

Sex/Gender

All

Inclusion criteria

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. - Glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol) (both inclusive) - body mass index (BMI) at least 25 and below 40 kg/m^2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 368 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 127

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate superiority of subcutaneously co administered semaglutide and NNC0480-0389 (in different dose ratios) versus placebo on change in HbA1c (%-point) from baseline to week 34 in participants with T2D inadequately controlled on diet and exercise with or without metformin.;Secondary Objective: - To demonstrate superiority of subcutaneously (s.c.; under the skin) co-administered semaglutide & NNC0480-0389 (in different dose ratios) versus (vs.) NNC0480-0389 and vs. semaglutide on change in HbA1c from baseline to week 34 in participants with T2D inadequately controlled on diet and exercise with/without metformin. To compare the following in participants with T2D inadequately controlled on diet and exercise with/without metformin: - Effect of s.c. administered NNC0480-0389 monotherapy vs. placebo on change in HbA1c from baseline to week 34. - Effect of s.c. co administered semaglutide & NNC0480 0389 (in different dose ratios) vs. placebo, vs. NNC0480-0389 and vs. semaglutide on change in fasting plasma glucose as well as body weight-related and cardio-metabolic parameters from baseline to week 34. - Safety and tolerability of s.c. co administered semaglutide and NNC0480-0389 (in different dose ratios) vs. placebo, vs. NNC0480-0389 and vs. semaglutide.;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to visit 19 (week 34)	—

Measure

Time frame

Main Objective: To demonstrate superiority of subcutaneously co administered semaglutide and NNC0480-0389 (in different dose ratios) versus placebo on change in HbA1c (%-point) from baseline to week 34 in participants with T2D inadequately controlled on diet and exercise with or without metformin.;Secondary Objective: - To demonstrate superiority of subcutaneously (s.c.; under the skin) co-administered semaglutide & NNC0480-0389 (in different dose ratios) versus (vs.) NNC0480-0389 and vs. semaglutide on change in HbA1c from baseline to week 34 in participants with T2D inadequately controlled on diet and exercise with/without metformin. To compare the following in participants with T2D inadequately controlled on diet and exercise with/without metformin: - Effect of s.c. administered NNC0480-0389 monotherapy vs. placebo on change in HbA1c from baseline to week 34. - Effect of s.c. co administered semaglutide & NNC0480 0389 (in different dose ratios) vs. placebo, vs. NNC0480-0389 and vs. semaglutide on change in fasting plasma glucose as well as body weight-related and cardio-metabolic parameters from baseline to week 34. - Safety and tolerability of s.c. co administered semaglutide and NNC0480-0389 (in different dose ratios) vs. placebo, vs. NNC0480-0389 and vs. semaglutide.;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to visit 19 (week 34)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in fasting plasma glucose 2. Change in body weight (kg) 3. Change in body weight (%) 4. Change in waist circumference 5. Change in systolic blood pressure (SBP) 6. Relative change in total cholesterol 7. Relative change in HDL cholesterol 8. Relative change in LDL cholesterol 9. Relative change in VLDL cholesterol 10.Relative change in triglycerides 11. Relative change in free fatty acids 12. Relative change in Apolipoprotein B 13. Relative change in high sensitivity C-Reactive Protein (hsCRP) 14. Number of treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1.-13. From baseline (week 0) to visit 19 (week 34) 14. From baseline (week 0) to visit 20 (week 39)	—

Measure

Time frame

Secondary end point(s): 1. Change in fasting plasma glucose 2. Change in body weight (kg) 3. Change in body weight (%) 4. Change in waist circumference 5. Change in systolic blood pressure (SBP) 6. Relative change in total cholesterol 7. Relative change in HDL cholesterol 8. Relative change in LDL cholesterol 9. Relative change in VLDL cholesterol 10.Relative change in triglycerides 11. Relative change in free fatty acids 12. Relative change in Apolipoprotein B 13. Relative change in high sensitivity C-Reactive Protein (hsCRP) 14. Number of treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1.-13. From baseline (week 0) to visit 19 (week 34) 14. From baseline (week 0) to visit 20 (week 39)

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Countries

Bulgaria, Denmark, European Union, Greece, Hungary, Japan, Russian Federation, Serbia, United States

Contacts

Public ContactClinical Transparency (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026