Decreased appetite Trials in Disease

Study of ART27.13 for Patients with Cancer-Related Anorexia and Weight Loss

This clinical trial is investigating a new treatment for patients experiencing cancer-related anorexia and significant weight loss. The condition being studied involves a loss of appetite and unintentional weight loss that often occurs in people with cancer, leading to muscle wasting and reduced quality of life.

Main inclusion criteria:

• Adults aged 18 years or older with confirmed cancer
• Self-reported decrease in appetite or dislike of food
• Unintentional weight loss of more than 5% of body weight over the past 6 months
• Life expectancy of at least 12 weeks
• Karnofsky Performance Status above 50, indicating ability to perform daily activities
• Adequate blood, kidney, and liver function based on laboratory tests
• Either not receiving anti-cancer therapy for 2 weeks before enrollment or on a stable dose of anti-cancer treatment
• Agreement not to drive or operate heavy machinery for at least the first 4 weeks of treatment due to potential side effects like dizziness and sleepiness

Main exclusion criteria:

• Patients with a different medical condition than cancer anorexia
• Currently participating in another clinical trial
• Recent surgery or medical procedures that might affect study results
• Pregnancy or breastfeeding
• History of allergic reactions to the study medication or similar medications
• Unable to follow study procedures or provide informed consent
• Any other medical condition that might interfere with the study or make participation unsafe

Focus and goal:

The trial is testing ART27.13, a synthetic cannabinoid designed to mimic the effects of naturally occurring compounds found in cannabis. The medication is taken orally as a hard capsule. The main goal is to determine whether ART27.13 can help patients gain weight, increase lean body mass (muscle), improve appetite, and enhance overall well-being.

The study lasts for 12 weeks, during which some participants will receive ART27.13 while others receive a placebo that looks identical but contains no active substance. The dose may be gradually adjusted every four weeks based on how patients respond. Throughout the trial, researchers will monitor changes in weight, body composition using DEXA scans, appetite levels, and quality of life through regular medical tests and questionnaires.

Investigational drug:

ART27.13 works at the molecular level by interacting with cannabinoid receptors in the body, which are part of the endocannabinoid system involved in regulating appetite and metabolism. It is classified as a cannabinoid receptor agonist. The study will also carefully monitor safety by checking for any side effects and assessing participants' overall health throughout the treatment period.