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NCT07042516 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
A Phase 2 study of Vasomotor Symptoms, sponsored by Tioga Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07042516: Recruiting Phase 2 study of Vasomotor Symptoms, sponsored by Tioga Pharmaceuticals.
NCT07042516 is a Phase 2 study of Vasomotor Symptoms that is actively recruiting participants, run by Tioga Pharmaceuticals. The registered enrollment target is 120 participants, below the 184-participant average among 8 other Vasomotor Symptoms trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07042516, a Phase 2 study of Vasomotor Symptoms, is actively recruiting participants, sponsored by Tioga Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This Randomized Clinical Trial entitled Safety and Efficacy of a Peripherally Restricted Selective Kappa Agonist for Moderate to Severe Menopausal Symptoms in Midlife Women is a Phase 2a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of asimadoline TP0052 for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). The design includes: 2 weeks of daily recording of VMS prior to drug treatment; 8 weeks of double-blind treatment with the peripherally restricted kappa agonist (PRKA), asimadoline TP0052, or placebo; and a safety telephone follow-up post-treatment; after the initial 8-week double-blinded follow-up, all patients undergo treatment with Asimadoline in an open label format for 4 weeks.
Primary Outcome
Safety will be evaluated based on the incidence and severity of adverse events and changes from baseline in laboratory values and vital signs. Adverse events will be graded using the Common Terminology Criteria for Adverse Events, Version 5.0 (grade 1 = mild; grade 5 = death; higher scores indicate worse outcomes). Liver function tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin. Higher values indicate worse
Conditions Studied
Interventions
- DRUG Asimadoline
Study Locations (1)
Georgia
- Department of Gynecology & Obstetrics, Emory University School of Medicine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-08-13 |
| Est. Completion | 2027-02-20 |
| Phase | Phase 2 |
What NCT07042516 shows while recruiting
NCT07042516 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 184-participant average among 8 other Vasomotor Symptoms trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Vasomotor Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Asimadoline is the first listed.
NCT07042516 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07042516 about?
NCT07042516 is a clinical study titled "Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).". This Randomized Clinical Trial entitled Safety and Efficacy of a Peripherally Restricted Selective Kappa Agonist for Moderate to Severe Menopausal Symptoms in Midlife Women is a Phase 2a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of asimadoline TP0052 for t...
What is the current status of trial NCT07042516?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-08-13. Estimated completion is 2027-02-20.
What conditions does trial NCT07042516 study?
This clinical trial studies the following conditions: Vasomotor Symptoms.
What interventions are being tested in trial NCT07042516?
The interventions under investigation include: Asimadoline (DRUG).
Who is sponsoring clinical trial NCT07042516?
This trial is sponsored by Tioga Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07042516 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07042516's enrollment target sits among peer trials
120 4th of 8 higher than 5 of 8 other Vasomotor Symptoms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vasomotor Symptoms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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