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

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ClinicalTrials.gov Identifier: NCT01044108
Recruitment Status : Terminated (See detailed description)
First Posted : January 7, 2010
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC 0070-0002-0453 Drug: '2-0453 Drug: placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Actual Study Start Date : January 5, 2010
Actual Primary Completion Date : December 13, 2010
Actual Study Completion Date : September 20, 2011

Arm Intervention/treatment
Experimental: Trial, part 1 (males only) Drug: NNC 0070-0002-0453
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.
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.



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Terminal half-life (t½) [ Time Frame: After administration of a single dose of trial drug ]
  2. AUC 0-24h, area under the '2-453 concentration-time curve [ Time Frame: From 0 to 24 hours after steady state ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044108


Locations
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01044108     History of Changes
Other Study ID Numbers: NN9161-3749
U1111-1112-7351 ( Other Identifier: WHO )
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Obesity
Overweight
Nutrition Disorders
Overnutrition
Body Weight
Signs and Symptoms