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

Obesity Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01044108
• Other study ID #: NN9161-3749
• Secondary ID: U1111-1112-7351
• Status: Terminated
• Phase: Phase 1
• First received: January 6, 2010
• Last updated: July 25, 2017
• Start date: January 5, 2010
• Est. completion date: September 20, 2011

Study information

• Verified date: July 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: September 20, 2011
• Est. primary completion date: December 13, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC 0070-0002-0453
Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
• '2-0453
Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
• placebo
Placebo will be administered as a comparator at each dose level.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of adverse events		From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)
Secondary	Terminal half-life (t½)		After administration of a single dose of trial drug
Secondary	AUC 0-24h, area under the '2-453 concentration-time curve		From 0 to 24 hours after steady state

External Links

•   Clinical Trials at Novo Nordisk