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

Phase 1

Terminated

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: '2-0453; Drug: NNC 0070-0002-0453; Drug: placebo

• Registration Number: NCT01044108
• Lead Sponsor: Novo Nordisk A/S

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01-05
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2010-12-13
• Study Completion: 2011-09-20
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trial, part 1 (males only)	placebo	-
Trial, part 2 (males and females)	'2-0453	-
Trial, part 1 (males only)	NNC 0070-0002-0453	-
Trial, part 2 (males and females)	placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AUC 0-24h, area under the '2-453 concentration-time curve	From 0 to 24 hours after steady state
Terminal half-life (t½)	After administration of a single dose of trial drug

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Evansville, Indiana, United States