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A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NNC9204-0530

placebo

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

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

Inclusion Criteria:

Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.

Exclusion Criteria:

Haemoglobin A1c (HbA1c) equal or above 6.5%
Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening
Any prior obesity surgery or currently present gastrointestinal implant.
Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
History of pancreatitis (acute or chronic)

Sites / Locations

Novo Nordisk Investigational Site
Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC9204-0530

Placebo

Arm Description

Dose-escalation within the cohort before reaching final dose

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events

Secondary Outcome Measures

Area under the NNC9204-0530 serum concentration-time curve

Time to maximum serum concentration of NNC9204-0530

Change in HbA1c

Full Information

NCT ID

NCT02835235

First Posted

July 13, 2016

Last Updated

January 5, 2018

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02835235

Brief Title

A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Official Title

A Double-blinded Placebo-controlled Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

July 26, 2016 (Actual)

Primary Completion Date

July 7, 2017 (Actual)

Study Completion Date

July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects being overweight or with obesity

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

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC9204-0530

Arm Type

Experimental

Arm Description

Dose-escalation within the cohort before reaching final dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC9204-0530

Intervention Description

Administered daily subcutaneously (s.c., under the skin)

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Administered daily subcutaneously (s.c., under the skin)

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events

Time Frame

Day 1-112

Secondary Outcome Measure Information:

Title

Area under the NNC9204-0530 serum concentration-time curve

Time Frame

Day 84-112

Title

Time to maximum serum concentration of NNC9204-0530

Time Frame

Day 84-112

Title

Change in HbA1c

Time Frame

Day -1, Day 85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening. Exclusion Criteria: Haemoglobin A1c (HbA1c) equal or above 6.5% Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening Any prior obesity surgery or currently present gastrointestinal implant. Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome) History of pancreatitis (acute or chronic)

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

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68502

Country

United States

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

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A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

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