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

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: NNC 0070-0002-0182; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00665665

NN9112-1846

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 4 patient groups

A

Experimental group

Treatment:

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: placebo

B

Experimental group

Treatment:

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: placebo

C

Experimental group

Treatment:

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: placebo

D

Experimental group

Treatment:

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: NNC 0070-0002-0182

Drug: placebo