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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958085
• Other study ID #: NN9838-4021
• Secondary ID: U1111-1131-7209
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2016
• Last updated: January 31, 2018
• Start date: November 4, 2016
• Est. completion date: January 24, 2018

Study information

• Verified date: January 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC0174-0833
Doses of NNC0174-0833, dosed either once daily or once weekly
• Placebo
Dosed either once daily or once weekly

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)		From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)
Secondary	The area under the NNC0174-0833 plasma concentration-time curve	[only applicable for once daily dosing]	From time 0 to 24 hours at steady state
Secondary	The area under the NNC0174-0833 plasma concentration-time curve	[only applicable for once weekly dosing]	From time 0 to 168 hours at steady state
Secondary	The maximum concentration of NNC0174-0833 in plasma at steady state		Day 1; Day 57