In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for underweight individuals. This trial is focused on testing an oral medication to help increase food intake in elderly patients who are underweight.
Clinical trial locations
- Netherlands
Study on the Effects of Oral Lidocaine (ORE-001) on Food Intake in Underweight Elderly Patients
This clinical trial is investigating whether an oral medication called ORE-001, which contains lidocaine, can help elderly people who are underweight to eat more food and improve their overall health. Lidocaine is commonly known as a local anesthetic, but in this study, researchers are testing whether it can help increase appetite when taken by mouth.
Who can participate:
- Adults between 65 and 85 years of age
- People with a Body Mass Index (BMI) of 20 or less
- Both men and women can participate
- Participants must be able to understand the study and provide written consent
- Male participants must use appropriate birth control methods if their partners can become pregnant
Who cannot participate:
- Individuals who are not underweight (the study specifically requires participants to have low body weight)
What the trial involves:
The study lasts for 42 days. Participants are randomly assigned to receive either ORE-001 tablets or a placebo (an inactive tablet that looks like the medication but contains no active ingredient). Throughout the study, researchers carefully monitor how much food participants eat during standardized lunches, particularly on days 1, 7, 14, and 42. They also track body weight changes and appetite sensations using questionnaires.
During the trial, participants undergo several assessments. At the beginning, baseline measurements are taken to establish starting points for food intake, body weight, and appetite levels. Throughout the treatment period, participants take their assigned medication as directed, and researchers record any changes in eating patterns and overall health. At the end of the 42 days, a final assessment measures whether there has been any improvement in food consumption and overall wellbeing.
The investigational drug:
ORE-001 is an oral form of lidocaine that is being tested to see if it can help increase food intake in elderly underweight individuals. The medication is taken by mouth in tablet form. Researchers hope that ORE-001 may influence the sensory pathways related to appetite regulation, potentially helping participants eat more and maintain a healthier body weight.
Summary
Currently, only one clinical trial is actively recruiting underweight patients, and it is taking place in the Netherlands. This trial focuses specifically on elderly individuals aged 65 to 85 with a BMI of 20 or below. The research is in its phase 2 stage, meaning that early testing has been completed and researchers are now evaluating both the safety and effectiveness of the treatment in a larger group of participants.
The trial represents an innovative approach to addressing underweight conditions in older adults by testing whether oral lidocaine can stimulate appetite and increase food consumption. The focus on elderly patients is particularly important, as this age group often faces challenges with maintaining adequate nutrition due to various factors including reduced appetite, medical conditions, and medication side effects.
For patients interested in participating, it is important to note that the study requires a commitment of 42 days and involves regular monitoring visits. The trial uses careful scientific methods, including comparison with a placebo, to determine whether the medication truly has beneficial effects on food intake and body weight.
