A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

NCT06326060
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Phase
Phase 2
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Recruitment status
Completed
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Participants
354
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Lead sponsor
Novo Nordisk A/S
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Start date
2024-03-18
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Number of sites
70
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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.
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Short title
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
clinicaltrials.gov
Official title
Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-05-01
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First posted
2024-03-22
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Registry last updated
2026-04-15
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Primary completion date
2025-04-10
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Start date
2024-03-18
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Actual participants
354
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Participants
354
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
70
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06326060
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ClinicalTrials.gov ID
NCT06326060
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Registry record
Open registry record
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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
clinicaltrials.gov

  1. Relative change in body weight

    Timeframe: From baseline (week 0) to end of treatment (week 36)

    Measured in percentage of body weight.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • jRCT2051230198
  • U1111-1291-9210
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)