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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665665

Enrollment

101

Registered

2008-04-24

Start date

2007-11-30

Completion date

2008-10-31

Last updated

2016-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and Nutrition Disorder, Obesity

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).

Interventions

DRUGNNC 0070-0002-0182

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

DRUGplacebo

Placebo for s.c. injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses	after 6 weeks

Secondary

Measure	Time frame
Assessment of changes in food consumption and hunger	at 6 weeks
Change in weight, waist and hip measurements and mood	at 6 weeks
Change in body composition and resting metabolism	at 6 weeks
Intervention arm D only: Change in insulin sensitivity (HOMA)	at 6 weeks
Pharmacokinetics of NNC 0070-0002-0182 and its isomer	at 8 weeks
Intervention arm D only: Change from baseline in indirect calorimetry	at 6 weeks
Intervention arm D only: Change from baseline in adiponectin, hsCRP	at 6 weeks
Intervention arm D only: Antibody assessment	at 10 weeks
Intervention arm D only: Change from baseline in body fat (DEXA)	at 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026