Effect of Quinine Hydrochloride in Overweight Population on Food Intake, Hunger and Gut Peptide Release

The Effect of Quinine Hydrochloride on Hedonic Food Intake, Appetite-related Sensations and Gastrointestinal Hormone Release in Overweight Female Subjects

Effect of Quinine Hydrochloride in Overweight Population on Food Intake, Hunger and Gut Peptide Release (NCT04873011) is a Phase 1 interventional studying Obesity, sponsored by Universitaire Ziekenhuizen KU Leuven. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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. Modulating the release of these hormones via bitter substances reduced appetite-related sensations and gastrointestinal motility in lean female volunteers. Intragastric administration of a quinine-solution has shown to decrease hunger sensations in healthy female volunteers. Now, we want to examine whether this effect is still seen in an overweight female population.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Obesity, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. - Subject understands the study procedures and agrees to participate in the study by giving written willing to sign a consent form. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion 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) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. * Subject understands the study procedures and agrees to participate in the study by giving written informed consent. Exclusion Criteria: * 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 (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study. * 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.

Treatments Being Tested

DRUG

Quinine Hydrochloride

After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of the quinine hydrochloride solution will be infused into the stomach in a randomized, double-blinded fashion

DRUG

Placebo

After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of water will be infused into the stomach in a randomized, double-blinded fashion

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

TARGID

Leuven, Vlaams-Brabant, Belgium

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04873011), the sponsor (Universitaire Ziekenhuizen KU Leuven), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04873011 clinical trial studying?

Who can participate in NCT04873011?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04873011?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04873011. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04873011. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.