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

NCT00728455 | Withdrawn Phase 1

• 1 other identifier: NN9112-1905
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)

  Including screening and evaluation: after approx. 7 weeks

Secondary Outcomes (4)

• 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

Study Arms (5)

A

EXPERIMENTAL

Drug: NNC 0070-0002-0349; Drug: placebo

B

EXPERIMENTAL

Drug: NNC 0070-0002-0349; Drug: placebo

C

EXPERIMENTAL

Drug: NNC 0070-0002-0349; Drug: placebo

D

EXPERIMENTAL

Drug: NNC 0070-0002-0349; Drug: placebo

E

EXPERIMENTAL

Drug: NNC 0070-0002-0349; Drug: placebo

Interventions

NNC 0070-0002-0349 DRUG

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

A

placebo DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 17, 2014

Record last verified: 2014-10