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Kisspeptin-10

KP-10, Metastin (45-54), Kisspeptin-10 (human), KiSS-1

Quick Stats
Studies 877
Trials 47
Terminated PHASE2 INTERVENTIONAL NCT02369796

A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism.

Detailed Description

The drug being tested in this study is called TAK-448. TAK-448 is being tested to treat overweight/obese males with hypogonadotropic hypogonadism. This study will look at the effects of TAK-448 on serum testosterone at different doses and different dosing frequencies. The study will enroll 15 patients. There will be 5 cohorts and participants will be assigned to cohorts in sequential order. Cohorts will be assigned to the following treatment groups: * TAK-448 3 µg once weekly * TAK-448 1 µg once weekly * TAK-448 0.3 µg once weekly * TAK-448 0.3 µg twice weekly * TAK-448 0.1 µg twice weekly All participants will be administered study drug via SC injection once or twice a week depending on their assigned cohort for four weeks. This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 32 days. Participants will make multiple visits to the clinic (depending once-weekly or twice-weekly dosing), and will be contacted by telephone 1 week after last dose of study drug for a follow-up assessment.

Interventions

Name: TAK-448
Type: DRUG
Description: TAK-448 solution for subcutaneous injection

Primary Outcomes

Measure: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups
TimeFrame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Description: Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measure: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups
TimeFrame: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Description: Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measure: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups
TimeFrame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Description: Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measure: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups
TimeFrame: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Description: Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measure: Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups
TimeFrame: Day 22 pre-dose
Description: Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measure: Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group
TimeFrame: Day 25 pre-dose
Description: Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measure: Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups
TimeFrame: Day 22 pre-dose
Description: Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measure: Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups
TimeFrame: Day 25 pre-dose
Description: Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.

Trial Information

NCT ID

NCT02369796

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Takeda

Last Updated

December 15, 2025