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Enobosarm · 2 trials · 5 indications
To determine the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists (percent change in total lean mass) at 112 days.
| Arm | Type | Description |
|---|---|---|
| Subcutaneous injectable semaglutide and oral enobosarm 3mg | EXPERIMENTAL | Approximately 100 subjects will be dosed for 476 days with semaglutide subcutaneous injection plus oral enobosarm 3 mg QD |
| Subcutaneous injectable semaglutide and oral Placebo | PLACEBO_COMPARATOR | Approximately 100 subjects will be dosed with semaglutide subcutaneous injection plus matching placebo |
| Semaglutide and Enobosarm 3 mg QD by mouth (E3G) daily | EXPERIMENTAL | Approximately 50 subjects will be dosed with semaglutide injected once-weekly and enobosarm 3 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive 3 mg enobosarm QD by mouth and will discontinue the semaglutide. |
| Semaglutide and Enobosarm 6 mg QD by mouth (E6G) daily | EXPERIMENTAL | Approximately 50 subjects will be dosed with semaglutide injected once-weekly and enobosarm 6 mg QD by mouth (E3G) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive 6 mg enobosarm QD by mouth and will discontinue the semaglutide. |
| GLP-1 receptor agonist and Placebo QD by mouth (PG) daily | PLACEBO_COMPARATOR | Approximately 50 subjects will be dosed with semaglutide injected once-weekly and placebo QD by mouth (PG) daily for approximately 112 days. Semaglutide dose escalation will occur as follows: Weeks 1 through 4 - 0.25mg Weeks 5 through 8 - 0.5mg Weeks 9 through 12 - 1mg Weeks 13 through 16 - 1.7mg From Day 112 to Day 196, patients will continue to receive placebo QD by mouth (PG) and will discontinue the semaglutide. |
| Name | Type | Description |
|---|---|---|
| Enobosarm | DRUG | Enobosarm is an oral, new chemical entity class, SARM, that has demonstrated tissue-selective, dose-dependent improvement in body composition with increases in muscle mass and reduces fat mass, improves insulin resistance, has no masculinizing effects in women, has neutral prostate effects in men, and no increases in hematocrit. Increases in muscle mass have resulted in improvements in muscle strength and physical function. |
| Semaglutide (Wegovy) weekly injection | DRUG | Semaglutide for Chronic Weight Management |
| Semaglutide | DRUG | Semaglutide for Chronic Weight Management |
Inclusion Criteria: * Subjects accepted for this study must: 1. Provide informed consent from the subject or the subject's legally authorized representative 2. Be able to communicate effectively with the study personnel 3. Be ≥65 years of age at the time of screening 4. For Female Subjects...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Abbott Laboratories | ABT | 1 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
Enobosarm is an investigational small molecule being studied for muscle loss, obesity, and overweight. It is being evaluated in patients taking GLP-1 receptor agonists for chronic weight management, with a focus on preserving or improving body composition and physical function.
Enobosarm targets the androgen receptor (AR) as a modulator. It is designed to act on this receptor to potentially influence muscle and fat metabolism, which is relevant to its study in conditions involving muscle loss and obesity.
Enobosarm is being developed by Veru Inc., a biopharmaceutical company. Veru is conducting clinical trials to evaluate the drug's effects on body composition and physical function in patients using GLP-1 receptor agonists for weight management.
Enobosarm is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for its potential role in managing muscle loss and obesity in patients on GLP-1 therapy.
Enobosarm has two Phase 2 trials. NCT06282458, a completed dose-finding study with 168 participants, evaluated body composition effects in patients taking a GLP-1 for chronic weight management. NCT07446998, an active but not recruiting proof-of-concept study with 239 participants, is evaluating total body weight, physical function, and safety in patients treated with a GLP-1 receptor agonist for weight loss.
Enobosarm is also known by the ChEMBL identifier CHEMBL1738889. This identifier is used in chemical and biological databases to reference the compound, which is being developed by Veru Inc. for metabolic conditions.