A Two Part Trial Investigating an Anti-obesity Drug in Ov... | NCT01044108

Studies
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers

NCT01044108

Sponsor

Novo Nordisk A/S

Status

Terminated

Last Update Posted

Jul 27, 2017Actual

Enrollment

117Actual

Phase

Phase 1

Conditions

Metabolism and Nutrition Disorder
Obesity

Interventions

NNC 0070-0002-0453
'2-0453
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1112-7351	Other Identifier	WHO

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

See detailed description

Expanded Access Info

Start Date

Jan 5, 2010Actual

Primary Completion Date

Dec 13, 2010Actual

Completion Date

Sep 20, 2011Actual

First Submitted Date

Jan 6, 2010

First Submission Date that Met QC Criteria

Jan 6, 2010

First Posted Date

Jan 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2017

Last Update Posted Date

Jul 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.

Detailed Description

Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial, part 1 (males only)	Experimental		Drug: NNC 0070-0002-0453 Drug: placebo
Trial, part 2 (males and females)	Experimental		Drug: '2-0453 Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NNC 0070-0002-0453	Drug	Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and severity of adverse events		From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)

Secondary Outcomes

Measure	Description	Time Frame
Terminal half-life (t½)		After administration of a single dose of trial drug
AUC 0-24h, area under the '2-453 concentration-time curve		From 0 to 24 hours after steady state

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

FOR TRIAL PART 1, THE FOLLOWING APPLIES:
Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
Good general health
FOR TRIAL PART 2, THE FOLLOWING APPLIES:
Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2
Good general health.

Exclusion Criteria:

Aggressive diet attempts within the last 3 months
Current or history of treatment with medications that may cause significant weight gain
History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour
History of eating disorders
Any weight change of 5 kg (11 pounds) in the last 3 months
Tobacco use
History of alcoholism or drug/chemical abuse

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Evansville	Indiana	47710	United States

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D009748	Nutrition Disorders
D009765	Obesity

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases
D050177	Overweight
D044343	Overnutrition
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided