> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-comparing-how-well-different-doses-of-the-3df0f1bd-ad74-42fc-9f12-e4315311a695 > Record changed: 2026-10-13 # A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight NCT06326060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) Participants 354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) Start date 2024-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) Number of sites 70 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Title and summary **Summary** This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130\. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Short title** A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Official title** Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Dates **Completion date** 2025-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **First posted** 2024-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Registry last updated** 2026-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Primary completion date** 2025-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Start date** 2024-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Size and sites **Actual participants** 354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Participants** 354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Number of sites** 70 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Identifiers **Registry ID** NCT06326060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **ClinicalTrials.gov ID** NCT06326060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Sponsor staff involved in the clinical trial is masked according to company standard procedures. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Outcomes ### Primary outcomes 1. Relative change in body weight Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in percentage of body weight. ### Secondary outcomes 1. Change in body weight Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in kilograms (kg) 2. Achievement of greater than equal to (≥) 5% weight reduction Timeframe: From baseline (week 0) to end of treatment (week 36) Count of participants 3. Achievement of ≥ 10% weight reduction Timeframe: From baseline (week 0) to end of treatment (week 36) Count of participants 4. Achievement of ≥ 15% weight reduction Timeframe: From baseline (week 0) to end of treatment (week 36) Count of participants 5. Achievement of ≥ 20% weight reduction Timeframe: From baseline (week 0) to end of treatment (week 36) Count of participants 6. Change in body mass index (BMI) Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in Kilogram per meter square (Kg/m\\^2) 7. Change in waist circumference Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in centimeter (cm) 8. Change in glycated hemoglobin (HbA1c) Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in percentage point (%-point) 9. Change in fasting plasma glucose (FPG) Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in millimoles per liter (mmol/L) 10. Change in systolic blood pressure (SBP) Timeframe: From baseline (week 0) to end of treatment (week 36) Measured in milliters of mercury (mmHg) 11. Change in high sensitivity C-Reactive protein (hsCRP) Timeframe: From baseline (week 0) to end of treatment (week 36) Ratio to baseline 12. Change in total cholesterol Timeframe: From baseline (week 0) to end of treatment (week 36) Ratio to baseline 13. Change in high-density lipoprotein (HDL) cholesterol Timeframe: From baseline (week 0) to end of treatment (week 36) Ratio to baseline 14. Change in low-density lipoprotein (LDL) cholesterol Timeframe: From baseline (week 0) to end of treatment (week 36) Ratio to baseline 15. Change in triglycerides Timeframe: From baseline (week 0) to end of treatment (week 36) Ratio to baseline 16. Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score Timeframe: From baseline (week 0) to end of treatment (week 36) IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100\. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). 17. Change in IWQOL-Lite-CT Psychosocial composite score Timeframe: From baseline (week 0) to end of treatment (week 36) IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100\. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). 18. Change in IWQOL-Lite-CT Physical Function score Timeframe: From baseline (week 0) to end of treatment (week 36) IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100\. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). 19. Change in IWQOL-Lite-CT Total score Timeframe: From baseline (week 0) to end of treatment (week 36) IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100\. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). 20. Number of adverse events Timeframe: From baseline (week 0) to end of treatment (week 40) Count of events Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - Female of non-childbearing potential, or male. a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male. - Age 18-75 years (both inclusive) at the time of signing the informed consent. - History of at least one self-reported unsuccessful dietary effort to lose body weight. - a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. - b) BMI ≥ 30.0 kg/m2. ### Exclusion criteria - HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening. - History of type 1 or type 2 diabetes mellitus. - Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Sites - Centricity Research-ArizonaMesa, United States - Arkansas Clinical ResearchLittle Rock, United States - Unity Health-Searcy Medical CenterSearcy, United States - FDRCCosta Mesa, United States - Encompass Clinical Research\_Spring ValleySpring Valley, United States - UCLA Health Southbay EndocrineTorrance, United States - Diablo Clinical Research, Inc.Walnut Creek, United States - Univ of Colorado at DenverAurora, United States - Nature Coast Clinical ResearchCrystal River, United States - Northeast Research InstituteFleming Island, United States - Jacksonville Ctr For Clin ResJacksonville, United States - South Broward Research LLCMiramar, United States - Cedar-Crosse Research CenterChicago, United States - Midwest Inst For Clin ResIndianapolis, United States - Velocity Clin. Res ValparaisoValparaiso, United States - L-MARC Research CenterLouisville, United States - Centennial Medical GroupColumbia, United States - StudyMetrix Research LLCCity of Saint Peters, United States - NYU Bariatric Surgical CtrNew York, United States - Rochester Clinical Research, Inc.Rochester, United States - Velocity Clinical Res. Inc VestalVestal, United States - Medication Mgmnt, LLC\_GrnsboroGreensboro, United States - PharmQuest Life Sciences LLCGreensboro, United States - Physicians East EndocrinologyGreenville, United States - Piedmont Healthcare StatesvilleStatesville, United States And 45 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## References ### Other registry identifiers (2) - jRCT2051230198 - U1111-1291-9210 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326060) ## Related records ### Drugs (1) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.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) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [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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