Tradipitant for Nausea and Vomiting

No longer recruiting at 2 trial locations

Overseen By Vanda Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanda Pharmaceuticals

Disqualifiers: Gastrointestinal disorders, NK-1 intolerance, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Tradipitant to determine if it can reduce nausea and vomiting in individuals who are overweight or have class I or class II obesity. Participants will receive either Tradipitant or a placebo (a look-alike pill with no active ingredient) for about two weeks. The study seeks individuals without serious health issues or chronic diseases, particularly diabetes, and who have not experienced problems with certain medications in the past. Those who frequently experience nausea after using GLP-1R agonists (a type of medication that aids in weight loss) may find this trial suitable. As a Phase 2 trial, the study focuses on assessing Tradipitant's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been on any investigational medication in the past 60 days, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies found that tradipitant was well-tolerated. Research shows that patients taking tradipitant experienced a significant decrease in nausea compared to those on a placebo. These studies identified no major safety issues, suggesting that tradipitant is generally safe, with few reported side effects. However, ongoing trials must continue monitoring to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for nausea and vomiting, which typically focus on blocking chemical signals like serotonin or dopamine, Tradipitant works differently by targeting the neurokinin-1 (NK1) receptor. This unique mechanism can potentially offer relief for patients who don't respond well to current options, such as ondansetron or metoclopramide. Researchers are excited about Tradipitant because it may provide faster and more effective symptom control, expanding treatment possibilities for those in need.

What evidence suggests that Tradipitant might be an effective treatment for nausea and vomiting?

Research has shown that Tradipitant, which participants in this trial may receive, may help reduce nausea and vomiting. In studies, Tradipitant significantly lowered severe nausea and vomiting compared to a placebo. For instance, one study found that only 18.03% of participants experienced severe symptoms with Tradipitant, while 37.70% did with a placebo. Another study demonstrated that Tradipitant increased the number of days without nausea and reduced vomiting episodes. These findings suggest Tradipitant could effectively manage nausea and vomiting. ^{5 6 7 8 9}

Who Is on the Research Team?

Vanda Pharmaceuticals

Principal Investigator

Vanda Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for healthy overweight individuals or those with class I or II obesity who experience nausea and vomiting after using GLP-1R agonist medications. Specific eligibility details are not provided, but typically participants must meet certain health criteria to join.

Inclusion Criteria

I do not have serious health issues or diabetes.

Body Mass Index 25-40 kg/m^2 inclusive

Exclusion Criteria

History of intolerance and/or hypersensitivity to NK-1 receptor antagonists

I have a condition that affects my stomach or intestines.

History of intolerance and/or hypersensitivity to GLP-1 receptor agonists

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tradipitant or placebo BID for approximately 2 weeks

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Tradipitant

Trial Overview The study is testing the effectiveness of Tradipitant in reducing nausea and vomiting compared to a placebo in volunteers who have taken GLP-1R agonists. It's a controlled trial with two groups: one receiving Tradipitant and the other receiving a placebo.

How Is the Trial Designed?

Group I: Tradipitant Group Experimental Treatment 1 Intervention

Treatment with tradipitant BID for approximately 2 weeks

Group II: Placebo Group Placebo Group 1 Intervention

Treatment with placebo BID for approximately 2 weeks

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Published Research Related to This Trial

In a study involving 126 adults, the NK1 receptor antagonist tradipitant significantly reduced the incidence of vomiting in participants experiencing motion sickness compared to a placebo, especially in rough sea conditions (tradipitant 15.79% vs. placebo 72.22%).

Tradipitant also led to lower overall motion sickness symptoms, with a mean severity score of 3.19 compared to 4.57 for the placebo group, indicating its potential as an effective treatment for nausea and vomiting associated with motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. Polymeropoulos, VM., Czeisler, MÉ., Gibson, MM., et al.[2023]

In a study involving 24 healthy volunteers, tradipitant (85 mg twice daily for 9 days) did not significantly affect gastric motor functions such as gastric emptying (GE) or gastric volumes (GV) compared to placebo.

The lack of impact on gastric emptying is crucial for considering tradipitant as a treatment option for patients with gastroparesis, as it suggests that the drug does not worsen this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Khanna, L., Zheng, T., Atieh, J., et al.[2022]

Aprepitant is safe and well tolerated in both healthy Chinese and Caucasian subjects, with no serious adverse events reported during the study.

The pharmacokinetics (PK) of aprepitant, including key measures like maximum plasma concentration and area under the concentration-time curve, were comparable between the two ethnic groups after a single dose, indicating similar drug behavior across populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Pharmacokinetics of Aprepitant in Healthy Chinese and Caucasian Subjects. Yang, MJ., Xu, HR., Li, H., et al.[2022]

In phase 3 trials involving patients receiving highly or moderately emetogenic chemotherapy, the addition of rolapitant to standard antiemetic therapy significantly improved quality of life, as measured by the Functional Living Index-Emesis (FLIE).

Rolapitant not only enhanced overall FLIE scores but also specifically reduced nausea and vomiting scores, with a higher percentage of patients reporting no impact on daily life compared to those receiving placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. Chasen, M., Urban, L., Schnadig, I., et al.[2019]

In a study of 401 patients receiving carboplatin-based chemotherapy, rolapitant significantly improved the complete response rate for preventing chemotherapy-induced nausea and vomiting (CINV), achieving 80.2% compared to 64.6% in the placebo group.

Rolapitant also demonstrated superior efficacy in preventing nausea and emesis during both the overall and delayed phases after chemotherapy, with a similar safety profile to the placebo, indicating it is a safe and effective addition to antiemetic regimens for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy. Hesketh, PJ., Schnadig, ID., Schwartzberg, LS., et al.[2022]

In a double-blind trial involving 152 adults with gastroparesis, the NK1 receptor antagonist tradipitant significantly reduced nausea severity and increased nausea-free days compared to placebo, demonstrating its efficacy in managing symptoms of this condition.

Patients with baseline nausea and vomiting experienced even greater improvements with tradipitant, highlighting its potential as a targeted treatment for those most affected by gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Carlin, JL., Lieberman, VR., Dahal, A., et al.[2021]

Aprepitant, the first neurokinin-1-receptor antagonist, significantly enhances protection against nausea and vomiting caused by cisplatin-based and moderately emetogenic chemotherapy, improving delayed emesis by about 20%.

Combining aprepitant with standard antiemetic treatments (5-HT(3) receptor antagonist and dexamethasone) provides better overall emesis control, suggesting this combination should be adopted as a new standard therapy for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurokinin-1-receptor antagonists: a new approach in antiemetic therapy. Jordan, K.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40103934/

tradipitant effective in the treatment of motion sickness; a ... Tradipitant prevented severe nausea and vomiting as compared to participants taking placebo (tradipitant = 18.03%, placebo = 37.70%, p < 0.0001) ...

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1550670/full

Motion Syros: tradipitant effective in the treatment of ... Tradipitant prevented severe nausea and vomiting as compared to participants taking placebo (tradipitant = 18.03%, placebo = 37.70%, p < 0.0001) ...

3. cghjournal.org cghjournal.org/article/S1542-3565(24)00050-8/fulltext

The Efficacy of Tradipitant in Patients With Diabetic ... Subjects with high blood levels of tradipitant significantly improved average nausea severity beginning at early time points (weeks 2–4). In ...

4. journals.lww.com journals.lww.com/ajg/fulltext/2022/10002/s1588_pooled_efficacy_analysis_of_tradipitant_in.1588.aspx

S1588 Pooled Efficacy Analysis of Tradipitant in Idiopathic . ... Significant improvement was seen in the number of nausea free days (20.96% improvement for tradipitant v. 12.52% for placebo, P=0.0085). Tradipitant also showed ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000205059

Tradipitant Effective in the Reduction of Vomiting ... Results: Participants on tradipitant 170 mg or 85 mg had a significantly lower incidence of vomiting as compared to those on placebo across all ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32693185/

Efficacy and Safety of Tradipitant in Patients With Diabetic ... Results: Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction ...

7. gastrojournal.org gastrojournal.org/article/S0016-5085(20)34958-1/fulltext

Efficacy and Safety of Tradipitant in Patients With Diabetic ... Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04028492

Study Details | NCT04028492 | Evaluating the Safety and ... Study Overview. Brief Summary. To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0016508520349581

Efficacy and Safety of Tradipitant in Patients With Diabetic ... Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P = .0099) and ...