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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC0194-0499; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	count of events	From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	measured in beats per minute	Baseline (Day 1), Follow-up (Day 112)
Change in biochemistry	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	Baseline (Day -1), Follow-up (Day 112)
Change in haematology	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	Baseline (Day -1), Follow-up (Day 112)
Change in fibrinogen	measured in g/L	Baseline (Day -1), Follow-up (Day 112)
Change in prothrombin time read as international normalised ratio (INR)		Baseline (Day -1), Follow-up (Day 112)
Change in activated partial thromboplastin time (APTT)	measured in seconds	Baseline (Day -1), Follow-up (Day 112)
Changes in electrocardiogram (ECG)	Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units	Baseline (Day 1), Follow-up (Day 112)
Number of injection site reactions	count of injection site reactions	From baseline (Day 1) to follow-up (Day 112)
Occurrence of anti-NNC0194-0499 antibodies		From baseline (Day 1) to follow-up (Day 112)
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state	Calculated based on serum concentrations of NNC0194-0499	From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state	Calculated based on serum concentrations of NNC0194-0499	From last dose (Day 78, pre-dose) until the follow-up (Day 112)
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state	Calculated based on serum concentrations of NNC0194-0499	From last dose (Day 78, pre-dose) until the follow-up (Day 112)
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state	Calculated based on serum concentrations of NNC0194-0499	From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Change in systolic blood pressure	measured in mmHg	Baseline (Day 1), Follow-up (Day 112)
Change in diastolic blood pressure	measured in mmHg	Baseline (Day 1), Follow-up (Day 112)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): June 4, 2019
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Body Weight; Obesity; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9499-4287; U1111-1193-7228 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No