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

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NNC0174-0833

Placebo

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

22 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0174-0833

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

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

[only applicable for once daily dosing]

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

[only applicable for once weekly dosing]

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

Full Information

NCT ID

NCT02958085

First Posted

November 2, 2016

Last Updated

January 31, 2018

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02958085

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 4, 2016 (Actual)

Primary Completion Date

January 24, 2018 (Actual)

Study Completion Date

January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0174-0833

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC0174-0833

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dosed either once daily or once weekly

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Description

[only applicable for once daily dosing]

Time Frame

From time 0 to 24 hours at steady state

Title

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

Description

[only applicable for once weekly dosing]

Time Frame

From time 0 to 168 hours at steady state

Title

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

Time Frame

Day 1; Day 57

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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