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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 NCT02381288

Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.

Detailed Description

The drug tested in this study is called TAK-448. TAK-448 was tested to define a dose and dose frequency which results in a clinically relevant improvement in ST in middle-aged and older men with low ST levels. This study looked at ST levels in men who took TAK-448. The study enrolled 17 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the following treatment groups-which remained undisclosed to the participants and study doctor during the study (unless there is an urgent medical need): * TAK-448 0.1 µg * TAK-448 0.3 µg * TAK-448 1.0 µg * Placebo (dummy inactive injection) - this was a injection that looks like the study drug but has no active ingredient All participants received subcutaneous injection either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36. This single-center trial was conducted in the United States. The overall time to participate in this study is up to 56 days. Participants made daily visits to the clinic for 8 weeks, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Interventions

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

Primary Outcomes

Measure: Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing
TimeFrame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Description: Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.
Measure: Trough Serum Concentration (Ctrough) of ST
TimeFrame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Description: Trough serum concentration of total and free ST, defined as lowest Baseline concentration.

Trial Information

NCT ID

NCT02381288

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Takeda

Last Updated

December 15, 2025