Endocrine profile of the kisspeptin receptor agonist MVT-602 in healthy premenopausal women with and without ovarian stimulation: results from 2 randomized, placebo-controlled clinical tricals.

Abbara A, Ufer M, Voors-Pette C, Berman L, Ezzati M, Wu R, Lee TY, Ferreira JCA, Migoya E, Dhillo WS

Fertility and sterility3 Nov 2023Cited by 12 (Europe PMC)

PMID37925096DOI10.1016/j.fertnstert.2023.10.031PepBankPUB-37925096

Publisher page PubMedAsk about this study

Summary

BackgroundKisspeptin is an essential regulator of hypothalamic gonadotropin-releasing hormone release and is required for physiological ovulation. Native kisspeptin-54 can induce oocyte maturation during in vitro fertilization treatment, including in women who are at high risk of ovarian hyperstimulation syndrome. MVT-602 is a potent kisspeptin receptor agonist with prospective utility to treat anovulatory disorders by triggering oocyte maturation and ovulation during medically assisted reproduction (MAR). Currently, the endocrine profile of MVT-602 during ovarian stimulation is unreported.ObjectiveTo determine the endocrine profile of MVT-602 in the follicular phase of healthy premenopausal women (phase-1 trial), and after minimal ovarian stimulation to more closely reflect the endocrine milieu encountered during MAR (phase-2a trial).DesignTwo randomized, placebo-controlled, parallel-group, dose-finding trials.SettingClinical trials unit.PatientsHealthy women aged 18-35 years, either without (phase-1; n = 24), or with ovarian stimulation (phase-2a; n = 75).InterventionsPhase-1: single subcutaneous dose of MVT-602 (0.3, 1.0, or 3.0 μg) or placebo, (n = 6 per dose). Phase-2a: single subcutaneous dose of MVT-602 (0.1, 0.3, 1.0, or 3.0 μg; n = 16-17 per dose), triptorelin 0.2 mg (n = 5; active comparator), or placebo (n = 5).Main outcome measuresPhase-1: safety/tolerability; pharmacokinetics; and pharmacodynamics (luteinizing hormone [LH] and other reproductive hormones). Phase-2a: safety/tolerability; pharmacokinetics; pharmacodynamics (LH and other reproductive hormones); and time to ovulation assessed by transvaginal ultrasound.ResultsIn both the trials, MVT-602 was safe and well tolerated across the entire dose range. It was rapidly absorbed and eliminated, with a mean elimination half-life of 1.3-2.2 hours. In the phase-2a trial, LH concentrations increased dose dependently; mean maximum change from baseline of 82.4 IU/L at 24.8 hours was observed after administration of 3 μg MVT-602 and remained >15 IU/L for 33 hours. Time to ovulation after drug administration was 3.3-3.9 days (MVT-602), 3.4 days (triptorelin), and 5.5 days (placebo). Ovulation occurred within 5 days of administration in 100% (3 μg), 88% (1 μg), 82% (0.3 μg), and 75% (0.1 μg), of women after MVT-602, 100% after triptorelin and 60% after placebo.ConclusionsMVT-602 induces LH concentrations of similar amplitude and duration as the physiological midcycle LH surge with potential utility for induction of oocyte maturation and ovulation during MAR.Clinical trial registration numberEUDRA-CT: 2017-003812-38, 2018-001379-20.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

01HumanRandomized controlled trialEfficacy outcome
In healthy women after ovarian stimulation, time to ovulation was 3.4 days after triptorelin versus 5.5 days after placebo.
In plain wordsAfter ovarian stimulation, women ovulated at 3.4 days after triptorelin versus 5.5 days after placebo.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseTime to ovulation
Study
n = 10
Comparator
Placebo
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.2 mgAs given in this study (human).
Measurements
Time to ovulation
3.4 days
triptorelin
Time to ovulation
5.5 days
placebo
Source sentences
Summary
Time to ovulation after drug administration was 3.3-3.9 days (MVT-602), 3.4 days (triptorelin), and 5.5 days (placebo).
2 context sentences(design, population, supporting numbers)
Summary · context
Healthy women aged 18-35 years, either without (phase-1; n = 24), or with ovarian stimulation (phase-2a; n = 75).
Summary · context
Phase-2a: single subcutaneous dose of MVT-602 (0.1, 0.3, 1.0, or 3.0 μg; n = 16-17 per dose), triptorelin 0.2 mg (n = 5; active comparator), or placebo (n = 5).
Show in the study text Report a problemFND-3792509601
02HumanRandomized controlled trialEfficacy outcome
In healthy women after ovarian stimulation, ovulation within 5 days occurred in 100% after triptorelin versus 60% after placebo.
In plain wordsAfter ovarian stimulation, 100% of women ovulated within 5 days after triptorelin versus 60% after placebo.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
IncreaseOvulation within 5 days
Study
n = 10
Comparator
Placebo
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.2 mgAs given in this study (human).
Measurements
Ovulation within 5 days
100%
triptorelin
Ovulation within 5 days
60%
placebo
Source sentences
Summary
Ovulation occurred within 5 days of administration in 100% (3 μg), 88% (1 μg), 82% (0.3 μg), and 75% (0.1 μg), of women after MVT-602, 100% after triptorelin and 60% after placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Healthy women aged 18-35 years, either without (phase-1; n = 24), or with ovarian stimulation (phase-2a; n = 75).
Summary · context
Phase-2a: single subcutaneous dose of MVT-602 (0.1, 0.3, 1.0, or 3.0 μg; n = 16-17 per dose), triptorelin 0.2 mg (n = 5; active comparator), or placebo (n = 5).
Show in the study text Report a problemFND-3792509602

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 2
13 Oct 2026, 21:44 UTC
Study results updated
Version 1
13 Oct 2026, 16:31 UTC
First added · source update from Europe PMC