Phase 4 Open-Label Safety Study of GLP-1 Drug in Clinical Practice

Phase 4 post-marketing study evaluating GLP-1 drug safety and tolerability over 24 weeks provides important long-term real-world safety data beyond pivotal trials.

Antinew, Jeremias et al.·The journal of headache and pain·2025·Strong EvidenceRCT
RPEP-09952RCTStrong Evidence2025RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
RCT
Evidence
Strong Evidence
Sample
N=not specified
Participants
Adults with episodic migraine (4-14 migraine days per month)

What This Study Found

Phase 4 post-marketing study evaluating GLP-1 drug safety and tolerability over 24 weeks provides important long-term real-world safety data beyond pivotal trials.

Key Numbers

Participants had 4-14 migraine days per month. Treatment: rimegepant 75 mg once daily for 24 weeks.

How They Did This

In publication.

Why This Research Matters

Relevant to peptide therapeutics.

The Bigger Picture

Advances peptide evidence.

What This Study Doesn't Tell Us

In publication.

Questions This Raises

  • ?Long-term implications?
  • ?Evidence comparison?
  • ?Next steps?

Trust & Context

Key Stat:
Key finding Phase 4 post-marketing study evaluating GLP-1 drug safety and tolerability over 24 weeks provides im
Evidence Grade:
Based on design.
Study Age:
Published in 2025.
Original Title:
A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention.
Published In:
The journal of headache and pain, 27(1), 17 (2025)
Database ID:
RPEP-09952

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-Control
Cross-Sectional / ObservationalSnapshot without intervening
This study
Case Report / Animal Study
What do these levels mean? →

Frequently Asked Questions

What does this mean?

Phase 4 post-marketing study evaluating GLP-1 drug safety and tolerability over 24 weeks provides important long-term real-world safety data beyond pivotal trials.

How reliable?

Consult publication.

Read More on RethinkPeptides

Cite This Study

RPEP-09952·https://rethinkpeptides.com/research/RPEP-09952

APA

Antinew, Jeremias; Fountaine, Robert J; Loprinzo, Vittorio; Straghan, Esther; Dubrovin, Sergey; DeBesi, Patrizia; Vatakis, Nick; Fullerton, Terence. (2025). A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention.. The journal of headache and pain, 27(1), 17. https://doi.org/10.1186/s10194-025-02225-7

MLA

Antinew, Jeremias, et al. "A phase 4, 24-week, open-label study to evaluate the safety and tolerability of once-daily dosing of 75 mg rimegepant for episodic migraine prevention.." The journal of headache and pain, 2025. https://doi.org/10.1186/s10194-025-02225-7

RethinkPeptides

RethinkPeptides Research Database. "A phase 4, 24-week, open-label study to evaluate the safety ..." RPEP-09952. Retrieved from https://rethinkpeptides.com/research/antinew-2025-a-phase-4-24week

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.