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Completed

NCT Number: NCT02941042

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.

Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, aged 18-55 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) at screening

Exclusion criteria

  • Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
  • Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention 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) 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 until 3 months following administration of the investigational medical product

Treatment and study plan

NNC9204-1177

Drug

A single dose administered subcutaneously ( s.c. under the skin)

Placebo

Drug

A single dose administered subcutaneously ( s.c. under the skin)

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)

Secondary outcomes

  1. Area under the NNC9204-1177 serum concentration-time curve

    Time frame: From 0 to 168 hours after a single s.c. dose

  2. Maximum serum concentration of NNC9204-1177

    Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)

    Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39

  3. Time to maximum serum concentration of NNC9204-1177

    Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 39)

    Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39

  4. Change in body weight

    Time frame: Day 1, day 39

  5. Change in QT interval corrected using the Fridericia formula (QTcF)

    Time frame: Day 1, day 39

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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