Clinical trial NCT01044108: A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-01-07
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and severity of adverse events
timeFrame: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)
Secondary outcomes:
measure: Terminal half-life (t½)
timeFrame: After administration of a single dose of trial drug
measure: AUC 0-24h, area under the '2-453 concentration-time curve
timeFrame: From 0 to 24 hours after steady state
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: