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Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT00665665
Recruitment Status : Terminated (The trial is terminated due to re-evaluation of the compound)
First Posted : April 24, 2008
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC 0070-0002-0182 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
Study Start Date : November 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: A Drug: NNC 0070-0002-0182
4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial

Drug: placebo
Placebo for s.c. injection

Experimental: B Drug: placebo
Placebo for s.c. injection

Drug: NNC 0070-0002-0182
12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial

Experimental: C Drug: placebo
Placebo for s.c. injection

Drug: NNC 0070-0002-0182
32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial

Experimental: D Drug: placebo
Placebo for s.c. injection

Drug: NNC 0070-0002-0182
60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial




Primary Outcome Measures :
  1. To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses [ Time Frame: after 6 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetics of NNC 0070-0002-0182 and its isomer [ Time Frame: at 8 weeks ]
  2. Assessment of changes in food consumption and hunger [ Time Frame: at 6 weeks ]
  3. Change in weight, waist and hip measurements and mood [ Time Frame: at 6 weeks ]
  4. Change in body composition and resting metabolism [ Time Frame: at 6 weeks ]
  5. Intervention arm D only: Change in insulin sensitivity (HOMA) [ Time Frame: at 6 weeks ]
  6. Intervention arm D only: Change from baseline in body fat (DEXA) [ Time Frame: at 6 weeks ]
  7. Intervention arm D only: Change from baseline in indirect calorimetry [ Time Frame: at 6 weeks ]
  8. Intervention arm D only: Change from baseline in adiponectin, hsCRP [ Time Frame: at 6 weeks ]
  9. Intervention arm D only: Antibody assessment [ Time Frame: at 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 30.0-39.0 kg/m2 (obese)
  • Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy

Exclusion Criteria:

  • Clinically significant diseases
  • Blood pressure greater than 140/90 mmHg
  • Evidence of depression
  • Recent diet attempts, treatment with diet drugs (within 3 months)
  • Liposuction or other surgery for weight loss within the last year
  • Evidence of eating disorders (bulimia, binge eating)
  • Restricted diets (Kosher, vegetarian)
  • Smoker or history of drug or alcohol abuse
  • Females of childbearing potential: positive pregnancy test

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): NCT00665665


Locations
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United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47710
United States, Wisconsin
Novo Nordisk Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00665665    
Other Study ID Numbers: NN9112-1846
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Nutrition Disorders
Overweight
Body Weight