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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 4, 2019

Interventions

  • 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.
  • Drug: Placebo
    • Participants will receive once weekly injections of NNC0194-0499 matched placebo.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in heart rate
    • Time Frame: Baseline (Day 1), Follow-up (Day 112)
    • measured in beats per minute
  • 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
  • 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
  • Change in fibrinogen
    • Time Frame: Baseline (Day -1), Follow-up (Day 112)
    • measured in g/L
  • Change in prothrombin time read as international normalised ratio (INR)
    • Time Frame: Baseline (Day -1), Follow-up (Day 112)
  • Change in activated partial thromboplastin time (APTT)
    • Time Frame: Baseline (Day -1), Follow-up (Day 112)
    • measured in seconds
  • 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
  • Number of injection site reactions
    • Time Frame: From baseline (Day 1) to follow-up (Day 112)
    • count of injection site reactions
  • Occurrence of anti-NNC0194-0499 antibodies
    • Time Frame: From baseline (Day 1) to follow-up (Day 112)
  • 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
  • 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
  • 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
  • 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
  • Change in systolic blood pressure
    • Time Frame: Baseline (Day 1), Follow-up (Day 112)
    • measured in mmHg
  • Change in diastolic blood pressure
    • Time Frame: Baseline (Day 1), Follow-up (Day 112)
    • measured in mmHg

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Reporting Anchor and Disclosure (1452), Study Director, Novo Nordisk A/S

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.