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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479892
• Other study ID #: NN9499-4287
• Secondary ID: U1111-1193-7228
• Status: Completed
• Phase: Phase 1
• Start date: March 13, 2018
• Est. completion date: June 4, 2019

Study information

• Verified date: June 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	count of events	From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
Secondary	Change in heart rate	measured in beats per minute	Baseline (Day 1), Follow-up (Day 112)
Secondary	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)
Secondary	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)
Secondary	Change in fibrinogen	measured in g/L	Baseline (Day -1), Follow-up (Day 112)
Secondary	Change in prothrombin time read as international normalised ratio (INR)		Baseline (Day -1), Follow-up (Day 112)
Secondary	Change in activated partial thromboplastin time (APTT)	measured in seconds	Baseline (Day -1), Follow-up (Day 112)
Secondary	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)
Secondary	Number of injection site reactions	count of injection site reactions	From baseline (Day 1) to follow-up (Day 112)
Secondary	Occurrence of anti-NNC0194-0499 antibodies		From baseline (Day 1) to follow-up (Day 112)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in systolic blood pressure	measured in mmHg	Baseline (Day 1), Follow-up (Day 112)
Secondary	Change in diastolic blood pressure	measured in mmHg	Baseline (Day 1), Follow-up (Day 112)