Tradipitant After GLP-1R Agonist In Healthy, Overweight, or Class I or II Obese Volunteers

Overview

About this study

The purpose of this study is to evaluate the effect of tradipitant relative to placebo on proportion of subjects with at least 1 vomiting episode per week during the evaluation phase as measured by a daily symptom diary over 1 week after administration of semaglutide.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Healthy male and female subjects aged 18 – 65 years (inclusive);
  • No serious medical problems or chronic diseases, specifically, no type 2 diabetes mellitus.
  • Body Mass Index (BMI) of ≥ 25 and ≤ 40 kg/m2 (BMI = weight (kg)/ [height (m)]2 );
  • Subjects must agree to the following study restrictions:
  • Males of procreative capacity (not surgically sterile) will use an acceptable method of contraception from randomization through 1 month following the last dose of study medication. Examples of acceptable contraception for males include abstinence, use of a barrier method, or sterilized or post-menopausal partner;
  • Females of child-bearing potential (not surgically sterile or post-menopausal, defined as 12 months without menses) will use an acceptable method of contraception from 1 month prior to randomization (or screening, if earlier) through 1 month following the last dose of study medication. Examples of acceptable methods of contraception for females include abstinence, double barrier method, IUD, hormonal contraception, or sterilized partner;
  • Ability and acceptance to provide written informed consent;
  • Willing to participate in the pharmacogenomics sample collection;
  • Willing and able to comply with all study requirements and restrictions
  • Willing to not participate in any other interventional trial for the duration of their participation

Exclusion Criteria:

  • Another disorder or treatment which could explain or contribute to gastrointestinal symptoms in the opinion of the Investigator (including but not limited to a previous diagnosis of gastroparesis, functional dyspepsia, chronic unexplained nausea and vomiting, gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
  • Current uncontrolled psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
  • Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
  • Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, gastric stimulation device,
  • Unexplained nausea or vomiting in the past 6 months
  • Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening as determined by the clinical investigator;
  • Major surgery, trauma (including broken pelvis/legs), illness (e.g. sepsis, stroke) or immobility for 3 or more days within the past month;
  • Active cancer or cancer treatment within the past 6 months;
  • Central venous catheter in place or within the past month;
  • Gastric or parenteral feeding within 4 weeks of screening;
  • Pregnancy or nursing;
  • History of intolerance and/or hypersensitivity to medications similar to semaglutide (glucagonlike peptide-1 agonist) and its accompanying excipients;
  • History (including family history) or current evidence of congenital long QT syndrome or known acquired QT interval prolongation (including QTc > 450 in males or > 470 in females at screening);
  • History of an eating disorder within 2 years of screening;
  • Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5 or evidence of such abuse which may include a positive drug screen at the Screening visit;
  • Uncontrolled blood glucose (including HbA1C >7 or metabolic crisis in past 60 days) or treatment with GLP-1 receptor agonist (e.g. dulaglutide, semaglutide, tirzepatide, exenatide, liraglutide) or amylin analog (pramlintide);
  • Indication of impaired liver function (including values for AST, ALT, or bilirubin > 2 times the Upper Limit of Normal (ULN), unless isolated bilirubin > 1.5 x ULN due solely to Gilbert’s syndrome);
  • Has a creatinine level > 2x ULN;
  • Use of medication with anti-nausea, antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the screening visit;
  • Refusal to abstain from use of any prescription, OTC medication or product that affects motion sickness or nausea for 1 week preceding and the day of Visit 2;
  • Previous experience with an oral or injectable GLP-1 agonist;
  • Use of the following within 2 weeks of screening: an other GLP-1 agonist, an NK-1 antagonist or a second generation 5-HT3 antagonist, amylin analogs (e.g. pramlintide), phenergan, or opioids more than 2 times per week;
  • Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 6 months of the Screening Visit;
  • Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
  • Anyone affiliated with the site or sponsor and/or anyone who may consent under duress; and
  • Any other reason as determined by the Investigator which may lead to an unfavorable riskbenefit of study participation, may interfere with study compliance, or may confound study results.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/18/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D., D.Sc.

Contact us for the latest status

Contact information:

Irene Busciglio

(507) 266-6615

Busciglio.irene@mayo.edu

More information

Publications

Publications are currently not available