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NCT Number: NCT03479892

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

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.

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Key information

Age range

22 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0194-0499

Drug

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

Drug

Participants will receive once weekly injections of NNC0194-0499 matched placebo.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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