A Two Part Trial Investigating an Anti-obesity Drug ('2-0453) in Overweight/Obese Male and Female Healthy Volunteers - Full Text View

Sponsor:	Novo Nordisk
Information provided by (Responsible Party):	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01044108

Purpose

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 '2-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.

Condition	Intervention	Phase
Healthy Obesity	Drug: '2-0453 Drug: placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Number and severity of adverse events [ Time Frame: from the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Terminal half-life (t½) [ Time Frame: after administration of a single dose of trial drug ] [ Designated as safety issue: No ]
AUC 0-24h, area under the '2-453 concentration-time curve [ Time Frame: from 0 to 24 hours after steady state ] [ Designated as safety issue: No ]

Enrollment:	117
Study Start Date:	January 2010
Study Completion Date:	September 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Trial, part 1 (males only)	Drug: '2-0453 Administration of a single subcutaneous (under the skin) dose of '2-0453. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation. Drug: placebo Placebo will be administered as a comparator at each dose level.
Experimental: Trial, part 2 (males and females)	Drug: '2-0453 Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation. Drug: placebo Placebo will be administered as a comparator at each dose level.

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044108

Locations

United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47710

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Birgit Sehested Hansen, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01044108 History of Changes
Other Study ID Numbers:	NN9161-3749, U1111-1112-7351
Study First Received:	January 6, 2010
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight

Signs and Symptoms
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012