Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN1033 · 6 trials · 3 indications
The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85).
The primary endpoint is percent change in total lean mass at week 12 (day 85)
The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study).
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Dosing regimen 1 |
| Group 2 | EXPERIMENTAL | Dosing regimen 2 |
| Group 3 | EXPERIMENTAL | Dosing regimen 3 |
| Group 4 | EXPERIMENTAL | Dosing regimen 4 |
| Panel A | EXPERIMENTAL | REGN1033 + REGN2477 (Regimen 1) or placebo |
| Panel B | EXPERIMENTAL | Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo |
| Panel C | EXPERIMENTAL | Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo |
| Panel D | EXPERIMENTAL | Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo |
| Panel E | EXPERIMENTAL | REGN2477 (Regimen 5) or placebo |
| Panel F | EXPERIMENTAL | REGN2477 + REGN1033 (Regimen 6) or placebo |
| Panel G | EXPERIMENTAL | REGN2477 (Regimen 7) or placebo |
| Reference Drug | EXPERIMENTAL | REGN1033 Reference Formulation |
| Test Drug | EXPERIMENTAL | REGN1033 Test Formulation |
| Cohort 1 | EXPERIMENTAL | Dose 1 of REGN1033 (SAR391786) or Placebo |
| Cohort 2 | EXPERIMENTAL | Dose 2 of REGN1033 (SAR391786) or Placebo |
| Cohort 3 | EXPERIMENTAL | Dose 3 of REGN1033 (SAR391786) or Placebo |
| Cohort 4 | EXPERIMENTAL | Dose regimen 4 (Participants 18 to ≤ 65 yrs old) |
| Cohort 5 | EXPERIMENTAL | Dose regimen 5 (Participants 18 to ≤ 65 yrs old) |
| Cohort 6 | EXPERIMENTAL | Dose regimen 6 (Participants 18 to ≤ 65 yrs old) |
| Cohort 7 | EXPERIMENTAL | Dose regimen 7 (Participants 18 to ≤ 65 yrs old) |
| Cohort 8 | EXPERIMENTAL | Dose regimen 3 (Participants \> 65 to ≤ 85 yrs old) |
| Cohort 9 | EXPERIMENTAL | Dose regimen 9 (Participants 18 to ≤ 65 yrs old) |
| Name | Type | Description |
|---|---|---|
| REGN1033 (SAR391786) | DRUG | - |
| placebo | DRUG | - |
| REGN1033 | DRUG | REGN1033 |
| REGN2477 | DRUG | REGN2477 |
| REGN1033(SAR391786) | DRUG | Administration method A |
Inclusion Criteria: 1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal) 2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions 3. Ability to follow a walking program 4. ...
REGN1033 is an investigational small molecule being studied for sarcopenia and in healthy volunteers. It is in Phase 1 clinical development by Regeneron Pharmaceuticals. The drug has been evaluated in four completed Phase 1 trials, all involving healthy volunteers, with a total enrollment of 343 participants.
REGN1033 is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The company has sponsored all four clinical trials of the drug, which are now completed. Regeneron is conducting the development program to assess the safety and tolerability of REGN1033.
REGN1033 is in Phase 1 clinical development. All four trials of the drug have been completed, and none are currently active. The Phase 1 program has studied the drug in healthy volunteers, including older adults, to evaluate safety, tolerability, and pharmacokinetics.
REGN1033 has been studied in four completed Phase 1 trials: NCT01507402, NCT01720576, NCT01910220, and NCT02943239. These trials assessed single and multiple ascending doses, safety and bioeffect, and the drug in combination with REGN2477. All trials enrolled healthy volunteers in the United States and New Zealand.
Yes, REGN1033 is also known as SAR391786. Several clinical trials, including NCT01507402 and NCT01720576, refer to the drug by this alternative name. The trials assess the safety and tolerability of REGN1033 (SAR391786) in healthy volunteers.