Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers

Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects

This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.

Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.

Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC 0070-0002-0349; Drug: NNC 0070-0002-0349; Drug: NNC 0070-0002-0349; Drug: NNC 0070-0002-0349; Drug: NNC 0070-0002-0349; Drug: placebo; Drug: placebo; Drug: placebo; Drug: placebo; Drug: placebo

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• BMI greater than 27.0 and less than 35.0 kg/m2

Exclusion Criteria:

• Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
• Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
• Eating disorders
• Unusual diets or eating habits
• Dieting, use of diet drugs or obesity surgery
• Diabetes history or abnormal fasting glucose

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E	Drug: NNC 0070-0002-0349; Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: NNC 0070-0002-0349; Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: placebo; Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection; Drug: placebo; Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection
Experimental: A	Drug: NNC 0070-0002-0349; Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: NNC 0070-0002-0349; Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: placebo; Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection; Drug: placebo; Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection
Experimental: B	Drug: NNC 0070-0002-0349; Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: NNC 0070-0002-0349; Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: placebo; Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection; Drug: placebo; Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection
Experimental: C	Drug: NNC 0070-0002-0349; Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: NNC 0070-0002-0349; Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: placebo; Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection; Drug: placebo; Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection
Experimental: D	Drug: NNC 0070-0002-0349; Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: NNC 0070-0002-0349; Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: NNC 0070-0002-0349; Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo); Drug: placebo; Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo; Drug: placebo; Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection; Drug: placebo; Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)	Including screening and evaluation: after approx. 7 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC (area under the curve)	21 days following dosing
Maximum plasma concentration	21 days following dosing
Time to maximum plasma concentration	21 days following dosing
Half life	21 days following dosing

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: July 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: July 31, 2008
• First Submitted That Met QC Criteria: July 31, 2008
• First Posted (Estimate): August 5, 2008

Study Record Updates

• Last Update Posted (Estimate): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9112-1905