Oslo Universitetssykehus HF
Oslo, Norway
RecruitingDecreased appetite
Study of ART27.13 for Patients with Cancer-Related Anorexia and Weight Loss
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a condition known as Cancer Anorexia, which involves a loss of appetite and weight loss in patients with cancer. The trial is testing a new treatment called ART27.13, a synthetic cannabinoid, which is a man-made substance similar to chemicals found in the cannabis plant. The purpose of the study is to explore how effective ART27.13 is in helping patients gain weight, increase lean body mass, and improve their appetite and overall well-being.
Participants in the study will receive ART27.13 in the form of a hard capsule taken by mouth. Some participants may receive a placebo, which looks like the treatment but does not contain the active substance. The study will last for 12 weeks, during which the dose of ART27.13 may be gradually increased every four weeks for some patients. The study aims to observe changes in weight, appetite, and quality of life over this period.
The trial will also monitor the safety of ART27.13 by checking for any side effects and assessing the overall health of participants through regular medical tests and questionnaires. This research is important for understanding how ART27.13 can potentially help people with cancer who are experiencing significant weight loss and appetite issues.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
16 criteria
- Have **cancer** (except those excluded by the exclusion criteria) confirmed by tests called **histopathology** or **cytology**.
- Understand and voluntarily sign and date an **Informed Consent Document (ICD)** before any study-related assessments or procedures.
- Willing and able to follow the study visit schedule and other study requirements.
- Agree not to drive or operate heavy machinery for the first 4 weeks of treatment or longer if side effects require it, as known side effects of ART27.13 include dizziness and sleepiness.
- Have **anorexia**, which means a self-reported decrease or lack of appetite or dislike of food.
- Have documented, unintentional weight loss of more than 5% of body weight and a continuous downward trend of weight loss in the past 6 months (plus or minus 2 weeks) from the date of enrollment.
- Patients are either: not on any anti-cancer therapy for the 2 weeks before enrollment and not expected to have anti-cancer therapy for the first 12 weeks after the first dose of ART27.13 (Stage 1) or if in Stage 2, after the start of ART27.13/placebo OR on stable dosing from 2 weeks before enrollment and expected to be on such therapy for another 12 weeks of anti-cancer therapies.
- Estimated life expectancy of at least 12 weeks as judged by the study doctor based on clinical impression.
- Have a **KPS** (Karnofsky Performance Status) of more than 50, which is a way to measure the ability to perform daily activities.
- At least 18 years of age at the time of enrollment.
- Have adequate blood, kidney, and liver function based on laboratory values obtained within 14 days of randomization, including:
- **Absolute neutrophil count** of at least 1.0 × 109/L
- **Platelets** of at least 75 × 109/L
- **Serum creatinine** no more than 1.5 times the upper limit of normal
- **Total serum bilirubin** no more than 1.5 times the upper limit of normal (up to 3.0 times if diagnosed with Gilbert’s syndrome or liver metastases)
- **Aspartate aminotransferase (AST)**, **alanine aminotransferase (ALT)**, and **alkaline phosphatase (AP)** no more than 2.5 times the upper limit of normal (up to 5.0 times if diagnosed with liver metastases)
- For women who can have children and for men with partners who can have children, agree to use birth control measures during treatments and for 6 months after the last study treatment.
Who cannot join the trial?
10 criteria
- Patients who have a different medical condition than the one being studied, which is **Cancer Anorexia**.
- Patients who are not within the specified age range for the study.
- Patients who are not able to follow the study procedures or take the study medication as required.
- Patients who are part of a vulnerable population, which means they might need special protection or care.
- Patients who are not able to provide consent to participate in the study.
- Patients who have any other medical condition that might interfere with the study or make it unsafe for them to participate.
- Patients who are currently participating in another clinical trial.
- Patients who have had a recent surgery or medical procedure that might affect the study results.
- Patients who are pregnant or breastfeeding.
- Patients who have a history of allergic reactions to the study medication or similar medications.
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Verified sites
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Verified Verified St. Olavs Hospital HF
Trondheim, NorwayVerified University Hospital Galway
Galway, Ireland
Trial locations
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Investigated drugs
ART27.13 is a synthetic cannabinoid being studied for its potential to help patients with cancer who are experiencing anorexia and weight loss. The trial aims to see if ART27.13 can help patients gain weight, increase lean body mass, improve their performance status, and reduce anorexia symptoms over a period of 12 weeks.
What is already known about the treatment
ART27.13 – This medication is administered orally and is currently being studied in clinical trials for its potential to treat cancer-related anorexia and weight loss. It is a synthetic cannabinoid, which means it is designed to mimic the effects of naturally occurring compounds found in cannabis. The main therapeutic goal is to help patients gain weight and improve their appetite. At the molecular level, ART27.13 works by interacting with cannabinoid receptors in the body, which are part of the endocannabinoid system involved in regulating appetite and metabolism. It is classified pharmacologically as a cannabinoid receptor agonist.
Investigated diseases
Cancer Anorexia – Cancer anorexia is a condition characterized by a significant loss of appetite and reduced food intake in individuals with cancer. This can lead to weight loss, muscle wasting, and a decrease in overall strength and energy levels. The progression of cancer anorexia often involves a complex interaction between the cancer itself, the body's response to the disease, and the side effects of cancer treatments. As the condition advances, patients may experience a decline in their physical function and quality of life. It is a common issue in cancer patients and can significantly impact their nutritional status and well-being.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-518177-33-00Protocol codeART27.13-100Estimated enrolment47 patientsSponsorArtelo Biosciences Limited
sourced from the EU Clinical Trials Register and site verification
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