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

Healios K.K.

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Obesity

Interventions

ATHX-105 phosphateDRUG

includes diet, physical activity, and lifestyle modification

PlaceboDRUG

includes diet, physical activity, and lifestyle modification

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in body weight

Time frame: 12 weeks

Secondary Outcomes

vital signs, lipids/glucose, waist circumference

Time frame: 12 weeks

Data from ClinicalTrials.gov

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