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

NCT01044108 | Terminated Phase 1

• 2 other identifiers: NN9161-3749U1111-1112-7351
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Trial, part 1 (males only)

EXPERIMENTAL

Drug: NNC 0070-0002-0453; Drug: placebo

Trial, part 2 (males and females)

EXPERIMENTAL

Drug: '2-0453; Drug: placebo

Interventions

NNC 0070-0002-0453 DRUG

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.

Trial, part 1 (males only)

'2-0453 DRUG

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.

Trial, part 2 (males and females)

placebo DRUG

Placebo will be administered as a comparator at each dose level.

Trial, part 1 (males only); Trial, part 2 (males and females)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Evansville, Indiana, 47710, United States

Location

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: January 5, 2010
• Primary Completion: December 13, 2010
• Study Completion: September 20, 2011
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

US (1)