NCT07446439

Brief Summary

The goal of this study is to measure the effects of using Tradipitant to treat nausea and vomiting induced by GLP-1R agonist use in adults with class I or class II obesity, or adults who are overweight with at least one weight-related condition. The study is placebo-controlled with two treatment arms.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
4mo left

Started Mar 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 10, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

March 27, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 20, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 10, 2026

Last Update Submit

April 14, 2026

Conditions

Nausea and VomitingObesity

Keywords

GLP-1R agonistSemaglutideNauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.

    A questionnaire called the Nausea Vomiting Daily Diary (NV-DD) will be completed once a day, which will be used to collect data for this endpoint. The NV-DD asks participants to record their vomiting frequency in a 24-hour period.

    1 week

Secondary Outcomes (2)

  • Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.

    1 week

  • To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week.

    1 week

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Treatment with placebo BID for approximately 2 weeks

Drug: Placebo

Tradipitant Group

EXPERIMENTAL

Treatment with tradipitant BID for approximately 2 weeks

Drug: Tradipitant

Interventions

TradipitantDRUG

Oral Capsule

Also known as: Nereus, VLY-686
Tradipitant Group
PlaceboDRUG

Oral Capsule

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index ≥ 25 and \< 40 kg/m\^2
  • No serious medical problems or chronic diseases, specifically no type I or type II diabetes

You may not qualify if:

  • Another disorder that contributes to gastrointestinal symptoms
  • History of intolerance and/or hypersensitivity to NK-1 receptor antagonists
  • History of intolerance and/or hypersensitivity to GLP-1 receptor agonists
  • Exposure to any investigational medication within the past 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Vanda Investigational Site

Los Angeles, California, 90025, United States

RECRUITING

Vanda Investigational Site

San Diego, California, 92108, United States

RECRUITING

Vanda Investigational Site

San Jose, California, 95124, United States

NOT YET RECRUITING

Vanda Investigational Site

Tampa, Florida, 33613, United States

RECRUITING

Vanda Investigational Site

Hamilton, New Jersey, 08690, United States

NOT YET RECRUITING

Vanda Investigational Site

New York, New York, 10016, United States

NOT YET RECRUITING

Vanda Investigational Site

Syosset, New York, 11791, United States

NOT YET RECRUITING

Vanda Investigational Site

Plano, Texas, 75024, United States

NOT YET RECRUITING

Vanda Investigational Site

San Antonio, Texas, 78215, United States

NOT YET RECRUITING

Vanda Investigational Site

Burke, Virginia, 22015, United States

NOT YET RECRUITING

MeSH Terms

Conditions

NauseaVomitingObesity

Interventions

LY686017

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Vanda Pharmaceuticals Inc.

    Vanda Pharmaceuticals Inc.

    STUDY DIRECTOR

Central Study Contacts

Vanda Pharmaceuticals

CONTACT

(202) 734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

March 3, 2026

Study Start

March 27, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(10)