Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss, Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 22 - 55 |
Updated: | 2/3/2018 |
Start Date: | November 4, 2016 |
End Date: | January 24, 2018 |
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.
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.
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
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