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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044108

Enrollment

117

Registered

2010-01-07

Start date

2010-01-05

Completion date

2011-09-20

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and Nutrition Disorder, Obesity

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.

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.

Interventions

DRUGNNC 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'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.

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026