First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03015207

Collaborator

(none)

Enrollment

Location

Arms

9.6

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 6, 2017

Actual Primary Completion Date :

Oct 26, 2017

Actual Study Completion Date :

Oct 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0194-0499 Injected s.c. /subcutaneously (under the skin)	Drug: NNC0194-0499
Placebo Comparator: Placebo Injected s.c. /subcutaneously (under the skin)	Drug: Placebo

Arm

Intervention/Treatment

Experimental: NNC0194-0499

Injected s.c. /subcutaneously (under the skin)

Drug: NNC0194-0499

Placebo Comparator: Placebo

Injected s.c. /subcutaneously (under the skin)

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Number of treatment-emergent adverse events (TEAEs) [From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)]

Secondary Outcome Measures

The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration [From pre-dose (day 1) until the followup (day 36)]
The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration [From pre-dose (day 1) until the followup (day 36)]
The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration [From pre-dose (day 1) until the followup (day 36)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Male, aged 22-55 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) guideline) risk above or equal to 5%
Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening (visit 1) until 3 months following administration of the investigational medical product
Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78209

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR,1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03015207

Other Study ID Numbers:

NN9499-4277
U1111-1181-9045

First Posted:

Jan 9, 2017

Last Update Posted:

Sep 5, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Obesity

Nutrition Disorders

Overweight

Study Results

No Results Posted as of Sep 5, 2018