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

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: NNC 0070-0002-0453; Drug: placebo; Drug: '2-0453

Study type: Interventional

Funder types: Industry

Identifiers

NCT01044108

U1111-1112-7351 (Other Identifier)

NN9161-3749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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117 participants in 2 patient groups

Trial, part 1 (males only)

Experimental group

Treatment:

Drug: NNC 0070-0002-0453

Drug: placebo

Trial, part 2 (males and females)

Experimental group

Treatment:

Drug: '2-0453

Drug: placebo