9 completed, 4 terminated, 3 withdrawn, 1 active not recruiting. 12 Phase 2, 4 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Withdrawn 3, Terminated 2, Active not recruiting 1 |
| Phase 3 | 4 | Completed 2, Terminated 2 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss Enobosarm, Semaglutide (Wegovy) weekly injection - Obesity & Overweight, Mobility Disability | Phase 2 | Active not recruiting | Veru Inc. | 239 | 2026-03-26 | 2026-09-04 |
| Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt Enobosarm, Semaglutide - Muscle Loss, Obesity | Phase 2 | Completed | Veru Inc. | 168 | 2024-04-29 | 2025-09-17 |
| Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant - Metastatic Breast Cancer | Phase 3 | Terminated | Veru Inc. | 5 | 2022-04-11 | 2024-02-26 |
| Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer Enobosarm, Exemestane - Metastatic Breast Cancer | Phase 3 | Terminated | Veru Inc. | 52 | 2021-10-12 | 2024-01-26 |
| Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence GTx-024 - Stress Urinary Incontinence | Phase 2 | Withdrawn | GTx | 2018-06-28 | 2024-03-01 | |
| Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence GTx-024, Matching Placebo - Stress Urinary Incontinence | Phase 2 | Withdrawn | GTx | 2018-05-28 | 2023-09-14 | |
| Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence GTx 024, Placebo - Stress Urinary Incontinence | Phase 2 | Completed | GTx | 491 | 2017-08-21 | 2021-03-24 |
| Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer Enobosarm, Laboratory Biomarker Analysis, Pembrolizumab - Androgen Receptor Positive, Estrogen Receptor Negative | Phase 2 | Completed | City of Hope Medical Center | 18 | 2017-06-01 | 2024-02-20 |
| Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density enobosarm - Mammographic Density | Phase 1 | Completed | Havah Therapeutics Pty Ltd | 9 | 2017-02-01 | 2018-04-18 |
| Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass GTx-024 9 or 18 mg - ER+ and AR+ Breast Cancer | Phase 2 | Withdrawn | GTx | 2016-04-01 | 2024-02-26 | |
| GTx-024 as a Treatment for Stress Urinary Incontinence in Women GTx-024 - Stress Urinary Incontinence | Phase 2 | Completed | GTx | 19 | 2016-01-01 | 2021-02-01 |
| Efficacy and Safety of GTx-024 in Patients With Estrogen Receptor (ER)+/Androgen Receptor (AR)+ Breast Cancer GTx-024 - ER+ and AR+ Breast Cancer | Phase 2 | Completed | GTx | 136 | 2015-08-01 | 2020-12-09 |
| Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC) GTx-024 - Triple Negative Breast Cancer | Phase 2 | Terminated | GTx | 32 | 2015-06-01 | 2020-11-18 |
| Phase II Study of GTx024 in Women With Metastatic Breast Cancer GTx-024 9mg - Metastatic Breast Cancer | Phase 2 | Terminated | GTx | 22 | 2013-04-01 | 2024-03-08 |
| Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum GTx-024, placebo - Muscle Wasting, Non-Small Cell Lung Cancer | Phase 3 | Completed | GTx | 330 | 2011-07-01 | 2020-11-09 |
| Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) GTx-024, placebo - Muscle Wasting, Non Small Cell Lung Cancer | Phase 3 | Completed | GTx | 321 | 2011-07-01 | 2016-03-03 |
| Study of GTx-024 on Muscle Wasting (Cachexia) Cancer. GTx-024, Placebo - Cachexia | Phase 2 | Completed | GTx | 159 | 2007-05-01 | 2014-07-11 |
Muscular Atrophy (4) · Urinary Incontinence, Stress (4) · Breast Neoplasms (3) · Carcinoma, Non-Small-Cell Lung (3) · Obesity (2) · Triple Negative Breast Neoplasms (2) · Bulbo-Spinal Atrophy, X-Linked (1) · Cachexia (1) · Colorectal Neoplasms (1) · Lymphoma, Non-Hodgkin (1) · Overweight (1)
GTx (11) · Veru Inc. (4) · City of Hope Medical Center (1) · Havah Therapeutics Pty Ltd (1)
United States (16) · Australia (1) · Canada (1) · Poland (1) · Spain (1) · Ukraine (1)
Kenneth Peters, MD (2) · Beth A Overmoyer, MD (1) · Hannah M Linden, MD (1) · Hope S Rugo, MD (1) · Kenneth M Peters, MD (1) · Kenneth M. Peters, MD (1) · Mayzie Johnston, PharmD (1) · Stephen N Birrell, MD PhD (1) · Yuan Yuan (1)