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

Phase 1TerminatedNCT00665665

Novo Nordisk A/S101 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

101

Conditions

Metabolism and Nutrition Disorder Obesity

Interventions

NNC 0070-0002-0182DRUG

4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial

placeboDRUG

Placebo for s.c. injection

NNC 0070-0002-0182DRUG

12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Novo Nordisk Investigational Site

Evansville, Indiana, United States

Novo Nordisk Investigational Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses

Time frame: after 6 weeks

Secondary Outcomes

Pharmacokinetics of NNC 0070-0002-0182 and its isomer

Time frame: at 8 weeks

Assessment of changes in food consumption and hunger

Time frame: at 6 weeks

Change in weight, waist and hip measurements and mood

Time frame: at 6 weeks

Change in body composition and resting metabolism

Time frame: at 6 weeks

Intervention arm D only: Change in insulin sensitivity (HOMA)

Time frame: at 6 weeks

Intervention arm D only: Change from baseline in body fat (DEXA)

Time frame: at 6 weeks

Intervention arm D only: Change from baseline in indirect calorimetry

Time frame: at 6 weeks

Intervention arm D only: Change from baseline in adiponectin, hsCRP

Time frame: at 6 weeks

Intervention arm D only: Antibody assessment

Time frame: at 10 weeks

Data from ClinicalTrials.gov

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