A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety

Healios

Status and phase: Withdrawn; Phase 2

Conditions: Obesity

Treatments: Drug: ATHX-105 phosphate; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00735683

A01-03

Details and patient eligibility

About

This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.

Full description

The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited.

This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week period.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese adults with a body mass index of 30-45 kg/m2

Exclusion criteria

• Pregnancy
• Diabetes
• Adults with serious or unstable current or past medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 6 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: ATHX-105 phosphate

3

Experimental group

Treatment:

Drug: ATHX-105 phosphate

4

Experimental group

Treatment:

Drug: ATHX-105 phosphate

5

Experimental group

Treatment:

Drug: ATHX-105 phosphate

6

Experimental group

Treatment:

Drug: ATHX-105 phosphate