MVT-602: Research & Studies
Scientific evidence, clinical trials, and research findings
๐TL;DR
- โข2 clinical studies cited
- โขOverall evidence level: moderate
- โข7 research gaps identified
Research Studies
Kisspeptin Receptor Agonist Has Therapeutic Potential for Female Reproductive Disorders
MacLean DB, Matsui H, Suri A, et al. (2020) โข Journal of Clinical Investigation
Preclinical and Phase 1 clinical evaluation of MVT-602 demonstrating potent KISS1R agonism and a prolonged LH surge profile in healthy premenopausal women, with peak LH at 21-22 hours versus 4.7 hours for kisspeptin-54.
Key Findings
- MVT-602 produced dose-related LH increases in healthy premenopausal women
- Peak LH at 21-22 hours vs 4.7 hours for kisspeptin-54
- LH AUC approximately 4-fold greater than kisspeptin-54
- MVT-602 half-life approximately 108 minutes vs 28 minutes for kisspeptin-54
- Well tolerated with no serious adverse events
Limitations: Small sample size; healthy volunteers only (not IVF patients); single-dose study; no clinical outcomes (pregnancy rates) assessed
Endocrine Profile of the Kisspeptin Receptor Agonist MVT-602 in Healthy Premenopausal Women With and Without Ovarian Stimulation
Sheridan R, Decourt C, MacLean DB, et al. (2023) โข Fertility and Sterility
Combined results from Phase 1 (follicular phase) and Phase 2a (after ovarian stimulation) trials of MVT-602 in healthy premenopausal women. Confirmed the prolonged LH surge profile in both settings.
Key Findings
- Confirmed prolonged LH surge in both unstimulated and stimulated settings
- LH surge close to natural mid-cycle LH surge after ovarian stimulation
- High rates of ovulation observed in Phase 2a
- Generally well tolerated in both studies
Limitations: Healthy volunteer populations; minimal ovarian stimulation protocol (not full IVF stimulation); no egg retrieval or pregnancy outcomes assessed; relatively small sample sizes
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๐Research Gaps & Future Directions
- โขEfficacy in actual IVF egg retrieval cycles with full ovarian stimulation (pregnancy rates, oocyte quality, embryo development)
- โขHead-to-head comparison with hCG and GnRH agonist triggers in IVF
- โขOHSS rate reduction quantification in high-risk IVF populations
- โขOptimal dose selection for different IVF protocols and patient populations
- โขSafety and efficacy in women with polycystic ovary syndrome (PCOS), the highest-risk population for OHSS
- โขPotential applications in hypothalamic amenorrhea and other anovulatory disorders
- โขLong-term reproductive outcomes for children conceived using kisspeptin trigger protocols
Research Overview#
MVT-602 has been evaluated in two clinical trials (Phase 1 and Phase 2a) in healthy premenopausal women, with results published in peer-reviewed journals. The evidence demonstrates a prolonged, physiological LH surge suitable for IVF oocyte maturation triggering. However, the compound has not yet been tested in actual IVF cycles with clinical outcome measures.
Phase 1 Study: Follicular Phase#
The Phase 1 study (MacLean et al., 2020; PMID 33196464) evaluated single subcutaneous doses of MVT-602 in healthy premenopausal women during the follicular phase. This randomized, placebo-controlled trial was designed to characterize the endocrine profile and dose-response relationship.
Key Findings#
- MVT-602 produced dose-related increases in LH concentrations
- The LH surge peaked at 21-22 hours after MVT-602 (versus 4.7 hours for kisspeptin-54)
- The LH AUC was approximately 4-fold greater than kisspeptin-54
- FSH was also increased, consistent with the physiological kisspeptin-GnRH pathway
- MVT-602's half-life was approximately 108 minutes (versus 28 minutes for kisspeptin-54)
- No serious adverse events; treatment was well tolerated
The prolonged LH surge duration is clinically significant because the natural mid-cycle LH surge lasts approximately 48 hours, and a longer trigger-induced LH surge may better support oocyte maturation and corpus luteum formation.
Phase 2a Study: After Ovarian Stimulation#
The Phase 2a study (Sheridan et al., 2023; PMID 37925096) evaluated MVT-602 in healthy premenopausal women after minimal ovarian stimulation to model the endocrine environment of medically assisted reproduction.
Key Findings#
- The prolonged LH surge profile was maintained after ovarian stimulation
- The LH surge closely resembled the natural mid-cycle LH surge
- High rates of ovulation were observed
- Treatment was generally well tolerated
This study was important because it demonstrated that MVT-602's pharmacodynamic profile is preserved in the context of elevated estradiol and follicular development, which is the clinical scenario during IVF.
Context: Kisspeptin Triggering in IVF#
MVT-602 is part of a broader research effort to develop kisspeptin-based IVF triggers. Professor Waljit Dhillo's group at Imperial College London has conducted extensive work with native kisspeptin-54 as an IVF trigger, demonstrating:
- Kisspeptin-54 can trigger oocyte maturation with pregnancy rates comparable to hCG
- Zero cases of OHSS in kisspeptin-triggered cycles (versus 7% with hCG in high-risk patients)
- The physiological mechanism limits the sustained ovarian stimulation that causes OHSS
MVT-602 aims to improve on kisspeptin-54 by providing a longer, more robust LH surge that may improve oocyte maturation rates while maintaining the safety advantage.
Evidence Quality Assessment#
| Criterion | Assessment | Details |
|---|---|---|
| Study design | Phase 1/2a RCTs | Randomized, placebo-controlled |
| Sample size | Small | Early clinical development |
| Population | Healthy volunteers | Not IVF patients |
| Outcomes | Surrogate (LH levels) | No pregnancy or clinical outcomes |
| Publication | Peer-reviewed | JCI and Fertility & Sterility |
| Independent data | Limited | Additional kisspeptin-54 data from Imperial College |
| Regulatory pathway | Phase 2 | Under Myovant/Sumitomo development |
Related Reading#
Frequently Asked Questions About MVT-602
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.