> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-looking-at-how-well-a-combination-of-the-b9e04dd3-b61d-452c-adbe-2e6afaa0bb81 > Record changed: 2026-10-13 # A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes NCT05144984 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) Participants 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) Start date 2021-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) Number of sites 129 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Short title** A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Dates **Completion date** 2023-03-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **First posted** 2021-12-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Registry last updated** 2026-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Primary completion date** 2023-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Start date** 2021-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Size and sites **Actual participants** 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Participants** 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Number of sites** 129 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Identifiers **Registry ID** NCT05144984 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **ClinicalTrials.gov ID** NCT05144984 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Outcomes ### Primary outcomes 1. Change From Baseline in Glycosylated Haemoglobin (HbA1c) Timeframe: 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) Timeframe: 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 \[kg\]) Timeframe: 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 Timeframe: 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 Timeframe: 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) Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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 Timeframe: 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) Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Sites - Pinnacle Research Group LLCAnniston, United States - Synexus Clinical ResearchGlendale, United States - University of Arizona/Banner HealthPhoenix, United States - American Clinical TrialsBuena Park, United States - San Fernando Valley Hlth Inst, LLCCanoga Park, United States - Velocity Clin Res-Chula VistaChula Vista, United States - Headlands Research California, LLCEscondido, United States - Valley ResearchFresno, United States - Providence Medical FoundationFullerton, United States - Velocity Clinical Research San DiegoLa Mesa, United States - First Valley Med Grp LancasterLancaster, United States - Torrance Clin Res Inst, Inc.Lomita, United States - Velocity Clin Res Los AngelesLos Angeles, United States - Valley Clinical Trials, Inc.Northridge, United States - Artemis Insitute for Clin ResRiverside, United States - Artemis Institute for Clin ResSan Diego, United States - Shahram Jacobs MD Inc.Sherman Oaks, United States - Diablo Clinical Research, Inc.Walnut Creek, United States - Northeast Research InstituteJacksonville, United States - Reyes Clinical Research, IncMiami, United States - South Broward Research LLCMiramar, United States - Clinical Trial Res Assoc,IncPlantation, United States - Progressive Medical ResearchPort Orange, United States - Headlands Research - SarasotaSarasota, United States - Appalachian Clinical Res LLCAdairsville, United States And 104 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## References ### Other registry identifiers (3) - 2020-004863-14 - jRCT2031210474 - U1111-1259-2741 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05144984) ## Related records ### Drugs (1) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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