The effect of AOD9604 on weight loss in obese adults.

A Phase IIb, Randomised, Double-Blind, Placebo-Controlled Study To Assess The Efficacy, Safety And Tolerability Of 24 Weeks Treatment With Different Doses Of AOD9604 Tablets On Weight Loss In Obese Adults.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000067673

Acronym

The "Options" Study.

Enrollment

360

Registered

2005-08-02

Start date

2005-10-31

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of this study is to determine if daily doses of AOD9604 cause weight loss in obese adults.

Interventions

The treatment regimen consists of 6 months (24 weeks) of orally administered AOD9604 tablets (0.25 mg, 0.5 mg or 1 mg) once per day.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

BMI of >= 30 kg/m2 and = < 45 kg/m2 with a waist circumference of > = 102 cm (males) or >= 95 cm (females) who are otherwise healthy.

Exclusion criteria

Subjects taking regular medication, diabetes, hypertension, hypersensitivity to hGH-related products, severe or multiple allergies, dieting or participation in any weight reduction programme in the 3 months prior to screening.

Outcome results