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Completed

NCT Number: NCT02958085

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.

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Key information

Age range

22 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator

Exclusion criteria

  • History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention
  • History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure
  • History or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
  • Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and is 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) of childbearing potential (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 last dose of investigational medical product

Treatment and study plan

NNC0174-0833

Drug

Doses of NNC0174-0833, dosed either once daily or once weekly

Placebo

Drug

Dosed either once daily or once weekly

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)

Secondary outcomes

  1. The area under the NNC0174-0833 plasma concentration-time curve

    Time frame: From time 0 to 24 hours at steady state

    [only applicable for once daily dosing]

  2. The area under the NNC0174-0833 plasma concentration-time curve

    Time frame: From time 0 to 168 hours at steady state

    [only applicable for once weekly dosing]

  3. The maximum concentration of NNC0174-0833 in plasma at steady state

    Time frame: Day 1; Day 57

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2016
Registry last updated
Feb 1, 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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