A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
- Registration Number
- NCT06326060
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
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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.
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Age 18-75 years (both inclusive) at the time of signing the informed consent.
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History of at least one self-reported unsuccessful dietary effort to lose body weight.
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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.
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b) BMI ≥ 30.0 kg/m2.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing scheme a: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Dosing scheme b: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Dosing scheme c: NNC0519-0130 NNC0519-0130 Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks. Dosing scheme c: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Dosing scheme d: NNC0519-0130 NNC0519-0130 Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks. Dosing scheme g: Tirzepatide Tirzepatide Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks. Dosing scheme d: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Dosing scheme e: NNC0519-0130 NNC0519-0130 Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks. Dosing scheme e: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Dosing scheme f: Placebo Placebo Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. Dosing scheme a: NNC0519-0130 NNC0519-0130 Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks. Dosing scheme b: NNC0519-0130 NNC0519-0130 Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks. Dosing scheme f: NNC0519-0130 NNC0519-0130 Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 36) Measured in percentage of body weight.
- Secondary Outcome Measures
Name Time Method Change in body weight From baseline (week 0) to end of treatment (week 36) Measured in kilograms (kg)
Achievement of ≥ 10% weight reduction From baseline (week 0) to end of treatment (week 36) Count of participants
Achievement of ≥ 15% weight reduction From baseline (week 0) to end of treatment (week 36) Count of participants
Achievement of greater than equal to (≥) 5% weight reduction From baseline (week 0) to end of treatment (week 36) Count of participants
Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 36) Measured in Kilogram per meter square (Kg/m\^2)
Change in waist circumference From baseline (week 0) to end of treatment (week 36) Measured in centimeter (cm)
Change in glycated hemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 36) Measured in percentage point (%-point)
Change in low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Achievement of ≥ 20% weight reduction From baseline (week 0) to end of treatment (week 36) Count of participants
Change in systolic blood pressure (SBP) From baseline (week 0) to end of treatment (week 36) Measured in milliters of mercury (mmHg)
Change in high sensitivity C-Reactive protein (hsCRP) From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Change in fasting plasma glucose (FPG) From baseline (week 0) to end of treatment (week 36) Measured in millimoles per liter (mmol/L)
Change in total cholesterol From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score 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).
Change in triglycerides From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Change in IWQOL-Lite-CT Psychosocial composite score 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).
Change in IWQOL-Lite-CT Physical Function score 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).
Number of adverse events From baseline (week 0) to end of treatment (week 40) Count of events
Change in IWQOL-Lite-CT Total score 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).
Change in high-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 36) Ratio to baseline
Trial Locations
- Locations (44)
Accellacare
🇺🇸Wilmington, North Carolina, United States
Unity Health-Searcy Medical Center
🇺🇸Searcy, Arkansas, United States
FDRC
🇺🇸Costa Mesa, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Northeast Research Institute
🇺🇸Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
🇺🇸Jacksonville, Florida, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Midwest Inst For Clin Res
🇺🇸Indianapolis, Indiana, United States
Velocity Clin. Res Valparaiso
🇺🇸Valparaiso, Indiana, United States
Scroll for more (34 remaining)Accellacare🇺🇸Wilmington, North Carolina, United States