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Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03856047
Recruitment Status : Completed
First Posted : February 27, 2019
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: NNC0174-0833 Drug: Placebo (NNC0174-0833) Drug: Liraglutide 3.0 mg Drug: Placebo (Liraglutide 3.0 mg) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : March 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: NNC0174-0833, 4.5 mg
Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Experimental: NNC0174-0833, 2.4 mg
Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Experimental: NNC0174-0833, 1.2 mg
Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Experimental: NNC0174-0833, 0.6 mg
Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Experimental: NNC0174-0833 0.3 mg
Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo Comparator: Placebo 2.4 mg (NNC0174-0833)
Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo Comparator: Placebo 4.5 mg (NNC0174-0833)
Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo Comparator: Placebo 1.2 mg (NNC0174-0833)
Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo Comparator: Placebo 0.6 mg (NNC0174-0833)
Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo Comparator: Placebo 0.3 mg (NNC0174-0833)
Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Active Comparator: Liraglutide 3.0 mg
Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.
Drug: Liraglutide 3.0 mg
Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.

Placebo Comparator: Placebo 3.0 mg (Liraglutide)
Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.
Drug: Placebo (Liraglutide 3.0 mg)
Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Week 0, Week 26 ]
    Percent


Secondary Outcome Measures :
  1. Subjects who achieve 5 percent or more body weight reduction (yes/no) [ Time Frame: Week 26 ]
    Percentage of subjects

  2. Subjects who achieve 10 percent or more body weight reduction (yes/no) [ Time Frame: Week 26 ]
    Percentage of subjects

  3. Change in body weight (kg) [ Time Frame: Week 0, Week 26 ]
    Measured in kilograms

  4. Change in waist circumference (cm) [ Time Frame: Week 0, Week 26 ]
    Measured in centimeters

  5. Change in fasting lipids - total cholesterol [ Time Frame: Week 0, Week 26 ]
    Measured in mg/dL

  6. Change in fasting lipids - high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, Week 26 ]
    Measured in mg/dL

  7. Change in fasting lipids - low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, Week 26 ]
    Measured in mg/dL

  8. Change in fasting lipids - very low density lipoprotein (VLDL) cholesterol [ Time Frame: Week 0, Week 26 ]
    Measured in mg/dL

  9. Change in fasting lipids - triglycerides [ Time Frame: Week 0, Week 26 ]
    Measured in mg/dL

  10. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
    Measured in percentage-points

  11. Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 26 ]
    Measured in mg/dL

  12. Change in fasting insulin. [ Time Frame: Week 0, Week 26 ]
    Measured in μIU/mL

  13. Change in Homeostatic model assessment of insulin resistance (HOMA-IR) [ Time Frame: Week 0, Week 26 ]
    Measured in percentage-points

  14. Change in Homeostatic model assessment of β-cell function (HOMA-β) [ Time Frame: Week 0, Week 26 ]
    Measured in percentage-points

  15. Number of treatment emergent adverse events (TEAEs) from randomisation to end of trial [ Time Frame: Week 0-32 ]
    Measured in number of participants

  16. Number of treatment emergent serious adverse events (SAEs) [ Time Frame: Week 0-32 ]
    Measured in number of participants

  17. Occurrence of anti-drug antibodies towards NNC0174-0833 (yes/no) [ Time Frame: Week 0-32 ]
    Percentage of participants

  18. Change in systolic blood pressure [ Time Frame: Week 0, Week 26 ]
    Measured in mmHg

  19. Change in diastolic blood pressure [ Time Frame: Week 0, Week 26 ]
    Measured in mmHg

  20. Change in mean 24-hour systolic blood pressure [ Time Frame: Week 0, Week 26 ]
    Measured in mmHg

  21. Change in mean 24-hour diastolic blood pressure [ Time Frame: Week 0, Week 26 ]
    Measured in mmHg

  22. Change in pulse [ Time Frame: Week 0, Week 26 ]
    Measured in beats per minute

  23. Change in high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, Week 26 ]
    Measured in mg/L

  24. Change in plasminogen activator inhibitor-1 (PAI-1) activity [ Time Frame: Week 0, Week 26 ]
    Measured in mg/L

  25. Change in renin activity [ Time Frame: Week 0, Week 26 ]
    Measured in g/mL/h

  26. Change in aldosterone [ Time Frame: Week 0, Week 26 ]
    Measured in ng/dL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older at the time of signing the informed consent.
  • Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
  • BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).

Exclusion Criteria:

  • HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856047


Locations
Show Show 54 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03856047    
Other Study ID Numbers: NN9838-4433
U1111-1214-0429 ( Other Identifier: World Health Organization (WHO) )
2018-001945-14 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists