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New treatment option for Obesity
Official title Effect of Quinine Hydrochloride in Overweight Population on Food Intake, Hunger and Gut Peptide Release
ClinicalTrials.gov ID: NCT04873011
What this study is testing
What is Quinine Hydrochloride?
Quinine Hydrochloride is an investigational medicine, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The worldwide increase in the prevalence of obesity is a cause of great concern. Pharmacological treatment options are being explored at the moment with a major focus on the hormones produced by the gastrointestinal tract which regulate hunger and satiation/satiety.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- Subject is female between 18 and 65 years of age.
- Subject has a BMI between 25 and 30 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable...
- Women of child-bearing age agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as...
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
You likely can't join if
- Subject is under age of legal consent, male, pregnant or breastfeeding.
- Subject with a BMI ≤ 25 kg/m² or BMI ≥ 30 kg/m².
- Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- Subject is currently following a weight loss diet or other treatment for obesity.
- Subject has diabetes.
- Subject has a significant heart, lung, liver or kidney disease.
See the full eligibility criteria
- Subject is female between 18 and 65 years of age.
- Subject has a BMI between 25 and 30 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
- Women of child-bearing age agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year)...
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is under age of legal consent, male, pregnant or breastfeeding.
- Subject with a BMI ≤ 25 kg/m² or BMI ≥ 30 kg/m².
- Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- Subject is currently following a weight loss diet or other treatment for obesity.
- Subject has diabetes.
- Subject has a significant heart, lung, liver or kidney disease.
- Subject has a QT-interval \> 450 ms.
- Subject has any history of a neurological disorder.
- Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
- Subject has retinopathy.
- Subject suffers from psoriasis.
- Subject has porphyria.
- Subject has a hematologic disorder (e.g. hemolysis, thrombocytopenia).
- Subject shows abnormal eating behavior or has a history of an eating disorder.
- History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
- History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
- Subject consumes excessive amounts of alcohol, defined as \>14 units per week.
- Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including "recreational use") of any illicit drugs (including marijuana) or has a history of drug...
- High caffeine intake (\> 4 cups of coffee daily or equivalent).
- Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.