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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
Lead sponsor
Assets
NNC0480-0389 / Semaglutide
Listed sites
129
Recruiting sites
—
Enrollment
500
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥25•HbA1c 7-10%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (30)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
6 endpointsChange From Baseline in Body Weight (Kilogram [kg])
Time frame:Baseline (week 0), (week 34)
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilogram (kg) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | -8.9 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | -12 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | -10 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | -12 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | -9.8 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | -4.7 | — |
| Placebo | -2.6 | — |
Percent Change From Baseline in Body Weight
Time frame:Baseline (week 0), (week 34)
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percent Change of body weight | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | -9.3 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | -13 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | -11 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | -13 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | -10 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | -4.3 | — |
| Placebo | -2.7 | — |
Change From Baseline in Waist Circumference
Time frame:Baseline (week 0), (week 34)
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), Centimeter (cm) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | -8 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | -11 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | -9 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | -10 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | -8 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | -5 | — |
| Placebo | -3 | — |
Change From Baseline in Body Weight (Kilogram [kg])
Time frame:Baseline (week 0), (week 34)
Body weight, absolute change (kg)
change from baseline, improvement
Percent Change From Baseline in Body Weight
Time frame:Baseline (week 0), (week 34)
Body weight, % change
percent change from baseline, improvement
Change From Baseline in Waist Circumference
Time frame:Baseline (week 0), (week 34)
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange From Baseline in Glycosylated Haemoglobin (HbA1c)
Time frame:Baseline (week 0), (week 34)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage point of HbA1c | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | -2.3 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | -2.2 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | -2.2 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | -2.3 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | -2.3 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | -1.1 | — |
| Placebo | -0.4 | — |
Hypothetical estimand
Hypothetical estimand
Hypothetical estimand
Hypothetical estimand
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Time frame:Baseline (week 0), (week 34)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame:Baseline (week 0), (week 34)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), millimoles per litre (mmol/L) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | -3.9 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | -3.4 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | -3.8 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | -3.8 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | -3.6 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | -1.4 | — |
| Placebo | -0.1 | — |
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame:Baseline (week 0), (week 34)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Cardiometabolic biomarkers
18 endpointsChange From Baseline in Systolic Blood Pressure (SBP)
Time frame:Baseline (week 0), (week 34)
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), Millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | -6 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | -10 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | -9 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | -13 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | -5 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | -3 | — |
| Placebo | 0 | — |
Relative Change From Baseline in Total Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.94 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.89 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.90 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.90 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.93 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 1.00 | — |
| Placebo | 0.96 | — |
Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 1.05 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 1.06 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 1.07 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 1.00 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 1.04 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 1.04 | — |
| Placebo | 1.04 | — |
Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.95 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.85 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.91 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.88 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.95 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 0.96 | — |
| Placebo | 0.96 | — |
Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
VLDL, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.75 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.76 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.72 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.78 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.72 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 0.95 | — |
| Placebo | 0.86 | — |
Relative Change From Baseline in Triglycerides - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.75 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.76 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.72 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.78 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.72 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 0.96 | — |
| Placebo | 0.86 | — |
Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
Free fatty acids, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of free fatty acids | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.85 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.74 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.77 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.75 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.88 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 0.96 | — |
| Placebo | 0.91 | — |
Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
ApoB, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of ApoB | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.90 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.84 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.85 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.85 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.91 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 1.00 | — |
| Placebo | 0.94 | — |
Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
hs-CRP, change
ratio, improvement
LOINC 30522-7
Posted result
| Group | Value (geometric_mean), Ratio of hsCRP | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 0.56 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 0.54 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 0.64 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 0.66 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 0.61 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 0.82 | — |
| Placebo | 0.93 | — |
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame:Baseline (week 0), (week 34)
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Relative Change From Baseline in Total Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
HDL-C, change
ratio, improvement
LOINC 2085-9
Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
LDL-C, change
ratio, improvement
LOINC 13457-7
Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
VLDL, change
ratio, improvement
Relative Change From Baseline in Triglycerides - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
Triglycerides, change
ratio, improvement
LOINC 2571-8
Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
Free fatty acids, change
ratio, improvement
Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
ApoB, change
ratio, improvement
Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame:Baseline (week 0), (week 34)
hs-CRP, change
ratio, improvement
LOINC 30522-7
Safety / tolerability / PK
2 endpointsNumber of Treatment-Emergent Adverse Events (TEAEs)
Time frame:Baseline (week 0) to (week 39)
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Events | 95% CI |
|---|---|---|
| Semaglutide 2.4 mg + NNC0480-0389 2.4 mg | 229 | — |
| Semaglutide 2.4 mg + NNC0480-0389 7.2 mg | 304 | — |
| Semaglutide 2.4 mg + NNC0480-0389 12.0 mg | 206 | — |
| Semaglutide 2.4 mg + NNC0480-0389 21.6 mg | 308 | — |
| Semaglutide 2.4 mg + Placebo (NNC0480-0389) | 271 | — |
| NNC0480-0389 21.6 mg + Placebo (Semaglutide) | 240 | — |
| Placebo | 95 | — |
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame:Baseline (week 0) to (week 39)
Treatment-emergent AEs (any)
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.