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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC 0070-0002-0453; Drug: placebo; Drug: '2-0453

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial, part 1 (males only)	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.; Drug: placebo; Placebo will be administered as a comparator at each dose level.
Experimental: Trial, part 2 (males and females)	Drug: placebo; Placebo will be administered as a comparator at each dose level.; Drug: '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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2010
• Primary Completion (Actual): December 13, 2010
• Study Completion (Actual): September 20, 2011

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Body Weight; Obesity; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9161-3749; U1111-1112-7351 (Other Identifier: WHO)