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A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity

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ClinicalTrials.gov Identifier: NCT03479892
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC0194-0499 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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: A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: NNC0194-0499
Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
 Drug: NNC0194-0499

Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level.

Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
Placebo Comparator: Placebo
Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
 Drug: Placebo
Participants will receive once weekly injections of NNC0194-0499 matched placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112) ]
    count of events


Secondary Outcome Measures :
  1. Change in heart rate [ Time Frame: Baseline (Day 1), Follow-up (Day 112) ]
    measured in beats per minute

  2. Change in biochemistry [ Time Frame: Baseline (Day -1), Follow-up (Day 112) ]
    Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units

  3. Change in haematology [ Time Frame: Baseline (Day -1), Follow-up (Day 112) ]
    Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units

  4. Change in fibrinogen [ Time Frame: Baseline (Day -1), Follow-up (Day 112) ]
    measured in g/L

  5. Change in prothrombin time read as international normalised ratio (INR) [ Time Frame: Baseline (Day -1), Follow-up (Day 112) ]
  6. Change in activated partial thromboplastin time (APTT) [ Time Frame: Baseline (Day -1), Follow-up (Day 112) ]
    measured in seconds

  7. Changes in electrocardiogram (ECG) [ Time Frame: Baseline (Day 1), Follow-up (Day 112) ]
    Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units

  8. Number of injection site reactions [ Time Frame: From baseline (Day 1) to follow-up (Day 112) ]
    count of injection site reactions

  9. Occurrence of anti-NNC0194-0499 antibodies [ Time Frame: From baseline (Day 1) to follow-up (Day 112) ]
  10. t½,SS: the terminal serum half-life of NNC0194-0499 at steady state [ Time Frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112) ]
    Calculated based on serum concentrations of NNC0194-0499

  11. Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state [ Time Frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112) ]
    Calculated based on serum concentrations of NNC0194-0499

  12. tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state [ Time Frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112) ]
    Calculated based on serum concentrations of NNC0194-0499

  13. CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state [ Time Frame: From last dose (Day 78, pre-dose) until the follow-up (Day 112) ]
    Calculated based on serum concentrations of NNC0194-0499

  14. Change in systolic blood pressure [ Time Frame: Baseline (Day 1), Follow-up (Day 112) ]
    measured in mmHg

  15. Change in diastolic blood pressure [ Time Frame: Baseline (Day 1), Follow-up (Day 112) ]
    measured in mmHg


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
  • Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
  • Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
  • Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
  • Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit

Exclusion Criteria:

  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
  • History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
Contacts and Locations
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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): NCT03479892


Locations
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United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03479892    
Other Study ID Numbers: NN9499-4287
U1111-1193-7228 ( Other Identifier: World Health Organization (WHO) )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
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://www.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
Nutrition Disorders
Overweight
Overnutrition
Body Weight