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GLP-1 Receptor Agonist

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
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to visit 25 (week 39)

Summary

This trial is testing a combination of semaglutide and a new medicine to help people with type 2 diabetes control their blood sugar levels. Participants will receive weekly injections and be monitored over several months. The goal is to find the best doses for future studies. Semaglutide is approved for the treatment of type 2 diabetes, known for its efficacy in glycemic control and weight management.

Eligible Conditions
  • Type 2 Diabetes
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to visit 25 (week 39)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to visit 25 (week 39) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HbA1c
Secondary study objectives
Change in body weight (%)
Change in body weight (kg)
Change in fasting plasma glucose (FPG)
+11 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 2.4 mg + placebo (NNC0480-0389)Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.
Group II: NNC0480-0389 + placebo (semaglutide)Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)
Group III: 2.4 mg semaglutide + 7.2 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Group IV: 2.4 mg semaglutide + 21.6 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Group V: 2.4 mg semaglutide + 2.4 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.
Group VI: 2.4 mg semaglutide + 12.0 mg NNC0480-0389Experimental Treatment2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide
Group VII: Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Group VIII: Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Group IX: Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Group X: Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389)Placebo Group2 Interventions
subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (semaglutide)
2021
Completed Phase 3
~39110
NNC0480-0389
2021
Completed Phase 2
~720
Placebo (NNC080-0389)
2021
Completed Phase 2
~500
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,557 Previous Clinical Trials
2,445,810 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,865 Total Patients Enrolled
~125 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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