A Phase 2 interventional study of NNC0519-0130 and Placebo in Obesity, sponsored by Novo Nordisk A/S. Completed at 70 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 354 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Drug: NNC0519-0130
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Drug: Placebo
Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Drug: NNC0519-0130
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Drug: Placebo
Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Drug: NNC0519-0130
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Drug: Placebo
Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Drug: NNC0519-0130
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Drug: Placebo
Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Drug: NNC0519-0130
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Drug: Placebo
Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Drug: NNC0519-0130
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Drug: Placebo
Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Drug: Tirzepatide
NNC0519-0130 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Tirzepatide will be administered subcutaneously.
Relative change in body weight
Measured in percentage of body weight.
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body weight
Measured in kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of greater than equal to (≥) 5% weight reduction
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 10% weight reduction
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 15% weight reduction
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 20% weight reduction
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
Measured in Kilogram per meter square (Kg/m\^2)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
Measured in centimeter (cm)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in glycated hemoglobin (HbA1c)
Measured in percentage point (%-point)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
Measured in millimoles per liter (mmol/L)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
Measured in milliters of mercury (mmHg)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive protein (hsCRP)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
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).
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Psychosocial composite score
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).
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Physical Function score
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).
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in IWQOL-Lite-CT Total score
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).
Time frame: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Count of events
Time frame: From baseline (week 0) to end of treatment (week 40)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S