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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002979-95 | EudraCT Number |
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The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033.
The secondary objectives are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1033 | Drug | REGN1033 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Up to 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in thigh muscle volume as measured by MRI | Up to 28 weeks | |
| Change in thigh muscle volume as measured by MRI | Up to 28 weeks | |
| Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol Inclusion/Exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland | New Zealand | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40360471 | Derived | Gonzalez Trotter D, Donahue S, Wynne C, Ali S, Parasoglou P, Boyapati A, Mohammadi K, Musser BJ, Meier P, Mastaitis J, Sleeman MW, Glass DJ, Gasparino E, Trejos J, Davis JD, Hirshberg B, Pordy R, Yancopoulos GD, Herman GA. GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial. Nat Commun. 2025 May 13;16(1):4376. doi: 10.1038/s41467-025-59380-3. |
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REGN2477 + REGN1033 (Regimen 6) or placebo |
|
| Panel G | Experimental | REGN2477 (Regimen 7) or placebo |
|
| REGN2477 | Drug | REGN2477 |
|
| Placebo | Other | Placebo |
|
| Up to 28 weeks |
| Change in total body composition as measured by DXA | Up to 28 weeks |
| Change in regional body composition as measured by DXA | Up to 28 weeks |
| Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time | Up to 40 weeks |
| Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime | Up to 40 weeks |
| Change in total Activin A levels in blood | Up to 40 weeks |
| Change in total GDF8 levels in blood | Up to 32 weeks |
| Presence or absence of antibodies against REGN2477 and REGN1033 | Up to 40 weeks |
| Christchurch |
| New Zealand |