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Completed

NCT Number: NCT03095807

Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male 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: No

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

Inclusion criteria

  • Male subjects 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. Overweight should be due to excess of adipose tissue, as judged by the investigator

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 equal to or above 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 until 3 months following administration of the investigational medical product

Treatment and study plan

NNC9204-1706 A

Drug

Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.

Placebo

Drug

Administered subcutaneously (s.c., under the skin)

Primary outcomes

  1. Number of treatment-emergent adverse events (TEAEs)

    Time frame: From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)

    Count and % of events

Secondary outcomes

  1. Area under the NNC9204-1706 plasma concentration-time curve

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  2. Area under the NNC9204-1706 plasma concentration-time curve (0-24h)

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  3. Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  4. Maximal observed concentration of the NNC9204-1706 plasma concentration curve

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  5. Time to observed maximum concentration of NNC9204-1706 in plasma

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  6. Terminal half-life of NNC9204-1706

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  7. Mean residence time of NNC9204-1706

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  8. The apparent total plasma clearance of NNC9204-1706

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  9. The apparent volume of distribution of NNC9204-1706

    Time frame: Day 1- Day 7

    Calculated based on NNC9204-1706 measured in blood.

  10. Changes in Body weight

    Time frame: Day 1, Days 10-13

    Measured in kg and/or %

  11. Number of injection-site reactions

    Time frame: From the time of dosing (Day 1) to the follow-up visit (Days 10-13)

    Count of reactions

  12. Number of hypoglycaemic episodes

    Time frame: from time of dosing (Day 1) to the follow-up visit (Days 10-13)

    Count of episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2017
Registry last updated
Oct 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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