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

Novo Nordisk logo

Novo Nordisk

Status and phase

Terminated
Phase 1

Conditions

Metabolism and Nutrition Disorder
Obesity

Treatments

Drug: NNC 0070-0002-0453
Drug: placebo
Drug: '2-0453

Study type

Interventional

Funder types

Industry

Identifiers

NCT01044108
U1111-1112-7351 (Other Identifier)
NN9161-3749

Details and patient eligibility

About

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.

Full 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.

Enrollment

117 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

117 participants in 2 patient groups

Trial, part 1 (males only)
Experimental group
Treatment:
Drug: NNC 0070-0002-0453
Drug: placebo
Trial, part 2 (males and females)
Experimental group
Treatment:
Drug: '2-0453
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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