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

January 31, 2018 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Dosed either once daily or once weekly
Experimental: NNC0174-0833
Drug: NNC0174-0833
Doses of NNC0174-0833, dosed either once daily or once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
From time 0 to 24 hours at steady state
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]
From time 0 to 168 hours at steady state
The maximum concentration of NNC0174-0833 in plasma at steady state
Time Frame: Day 1; Day 57
Day 1; Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2016

Primary Completion (Actual)

January 24, 2018

Study Completion (Actual)

January 24, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9838-4021
  • U1111-1131-7209 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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