Hypogonadotropic Hypogonadism Clinical Trial
Official title:
An Open-Label, Phase 2a Study to Evaluate the Pharmacodynamics of Different Dosing Regimens of TAK-448, a Kisspeptin Agonist, in Male Overweight/Obese Participants With Hypogonadotropic Hypogonadism
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism (HH).
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 at different doses and different dosing frequencies on serum
testosterone.
The study will enroll approximately 48 patients. There will be 6 cohorts and participants
will be assigned to cohorts in sequential order. Cohort 1 will receive TAK-448 3 micrograms
(µg) subcutaneously (SC) once weekly for 4 weeks. The dose for Cohorts 2 and 3 will be
determined based on results from Cohort 1. Cohorts 2 and 3 will receive TAK-448 once weekly
for 4 weeks or twice weekly for 4 weeks. The TAK-448 dose and dosing frequency for Cohorts
4, 5 and 6 will be determined based on results from Cohorts 1, 2 and 3.
All participants will be administered study drug via SC injection once or twice a week
depending on their assigned cohort.
This single-centre trial will be conducted in the United Kingdom. The overall time to
participate in this study is up to 12 weeks. Participants will make 8 to 12 visits to the
clinic (depending once-weekly or twice-weekly dosing), and will be contacted by telephone 14
days after last dose of study drug for a follow-up assessment.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01438073 -
Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling
|
Phase 1 | |
| Completed |
NCT01403532 -
Sequential Therapy for Hypogonadotropic Hypogonadism
|
Phase 4 | |
| Recruiting |
NCT00456274 -
Baselines in Reproductive Disorders
|
N/A | |
| Terminated |
NCT05205837 -
A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial
|
Phase 4 | |
| Completed |
NCT02908074 -
A 6 Month Safety Extension Study of MBGS205
|
Phase 2 | |
| Completed |
NCT05752591 -
Hypothalamic-pituitary Dysfunction in Diabetes
|
||
| Terminated |
NCT03118479 -
Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
|
Phase 1 | |
| Completed |
NCT02730169 -
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
|
Phase 2 | |
| Completed |
NCT02110368 -
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
|
Phase 3 | |
| Recruiting |
NCT01601171 -
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
|
||
| Completed |
NCT01623570 -
Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP
|
N/A | |
| Terminated |
NCT00328926 -
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
|
Phase 4 | |
| Completed |
NCT01438034 -
Kisspeptin in the Evaluation of Delayed Puberty
|
Phase 1 | |
| Completed |
NCT04456296 -
A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
|
Phase 4 | |
| Recruiting |
NCT00914823 -
Kisspeptin Administration in the Adult
|
Phase 1 | |
| Terminated |
NCT01155518 -
Hypogonadism in Young Men With Type 2 Diabetes
|
Phase 2 | |
| Completed |
NCT00697814 -
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
|
Phase 2 | |
| Active, not recruiting |
NCT00351416 -
Letrozole Treatment in Normal and GnRH Deficient Women
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05971836 -
The Molecular Basis of Inherited Reproductive Disorders
|
||
| Recruiting |
NCT02705014 -
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
|
N/A |