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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 56
• 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: 22 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2017
• Primary Completion (ACTUAL): October 26, 2017
• Study Completion (ACTUAL): October 26, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (ESTIMATE): January 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Body Weight; Obesity; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9499-4277; U1111-1181-9045 (OTHER: WHO)