Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Novo Nordisk A/S
Study ID
NCT02235961
Phase
PHASE1
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • NNC9204-0530 — DRUG
    Administered as single subcutaneous (s.c., under the skin) injections.
  • liraglutide — DRUG
    Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.
  • placebo — DRUG
    Administered as single subcutaneous (s.c., under the skin) injections.

Study Details

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.

Key Dates

Start date
Sep 4, 2014
Status verified
Jul 2017
Primary completion
Jul 6, 2016
Completion
Jul 6, 2016

Study Design

Enrollment
163 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
  • Experimental: Part 2

Primary Outcome Measure

Number of treatment emergent adverse events recorded [ Time Frame: From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteOverland ParkKansas66212-

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