Secondary and Additional Efficacy Endpoints Evaluated at 12 Weeks After the Last Treatment
| Variables . | Placebo (n = 66) . | MEI005 (n = 120) . |
|---|---|---|
| MRI respondera, n (%) | 10 (15.2) | 60 (50.0) |
| Variables . | Placebo (n = 66) . | MEI005 (n = 120) . |
|---|---|---|
| MRI respondera, n (%) | 10 (15.2) | 60 (50.0) |
| . | Placebo (n = 103) . | MEI005 (n = 179) . |
|---|---|---|
| SMF reduction percentage by caliper, ±SD (%) | 6.32 ± 1.71 | 21.42 ± 1.95 |
| Reduction in PR-SMFIS scores, ±SD | 4.68 ± 13.47 | 22.58 ± 17.47 |
| . | Placebo (n = 103) . | MEI005 (n = 179) . |
|---|---|---|
| SMF reduction percentage by caliper, ±SD (%) | 6.32 ± 1.71 | 21.42 ± 1.95 |
| Reduction in PR-SMFIS scores, ±SD | 4.68 ± 13.47 | 22.58 ± 17.47 |
| . | Placebo (n = 111) . | MEI005 (n = 212) . |
|---|---|---|
| CR-SMFRS ≥1-grade improvement, n (%) | 30 (27.0) | 155 (73.1) |
| PR-SMFRS ≥1-grade improvement, n (%) | 52 (46.8) | 156 (73.6) |
| CR-SMFRS ≥2-grade improvement, n (%) | 4 (3.6) | 82 (38.7) |
| PR-SMFRS ≥2-grade improvement, n (%) | 6 (5.4) | 70 (33.0) |
| SSRS responder, n (%) | 17 (15.3) | 125 (59.0) |
| SGQ responder, n (%) | ||
| 1 (fat under chin) | 10 (9.0) | 127 (59.9) |
| 2 (definition between chin and neck) | 11 (9.9) | 109 (51.4) |
| 3 (satisfaction with the treatment) | 26 (23.4) | 143 (67.5) |
| . | Placebo (n = 111) . | MEI005 (n = 212) . |
|---|---|---|
| CR-SMFRS ≥1-grade improvement, n (%) | 30 (27.0) | 155 (73.1) |
| PR-SMFRS ≥1-grade improvement, n (%) | 52 (46.8) | 156 (73.6) |
| CR-SMFRS ≥2-grade improvement, n (%) | 4 (3.6) | 82 (38.7) |
| PR-SMFRS ≥2-grade improvement, n (%) | 6 (5.4) | 70 (33.0) |
| SSRS responder, n (%) | 17 (15.3) | 125 (59.0) |
| SGQ responder, n (%) | ||
| 1 (fat under chin) | 10 (9.0) | 127 (59.9) |
| 2 (definition between chin and neck) | 11 (9.9) | 109 (51.4) |
| 3 (satisfaction with the treatment) | 26 (23.4) | 143 (67.5) |
CR-SMFRS, Clinician-Reported Submental Fat Rating Scale; PR-SMFIS, Patient-Reported Submental Fat Impact Scale; PR-SMFRS, Patient-Reported Submental Fat Rating Scale; SD, standard deviation; SMF, submental fat; SSRS, Subject Self-Rating Scale; SGQ, Subject Global Questions.
aThe reduction in SMF volume is at least 10% compared with the baseline.
Secondary and Additional Efficacy Endpoints Evaluated at 12 Weeks After the Last Treatment
| Variables . | Placebo (n = 66) . | MEI005 (n = 120) . |
|---|---|---|
| MRI respondera, n (%) | 10 (15.2) | 60 (50.0) |
| Variables . | Placebo (n = 66) . | MEI005 (n = 120) . |
|---|---|---|
| MRI respondera, n (%) | 10 (15.2) | 60 (50.0) |
| . | Placebo (n = 103) . | MEI005 (n = 179) . |
|---|---|---|
| SMF reduction percentage by caliper, ±SD (%) | 6.32 ± 1.71 | 21.42 ± 1.95 |
| Reduction in PR-SMFIS scores, ±SD | 4.68 ± 13.47 | 22.58 ± 17.47 |
| . | Placebo (n = 103) . | MEI005 (n = 179) . |
|---|---|---|
| SMF reduction percentage by caliper, ±SD (%) | 6.32 ± 1.71 | 21.42 ± 1.95 |
| Reduction in PR-SMFIS scores, ±SD | 4.68 ± 13.47 | 22.58 ± 17.47 |
| . | Placebo (n = 111) . | MEI005 (n = 212) . |
|---|---|---|
| CR-SMFRS ≥1-grade improvement, n (%) | 30 (27.0) | 155 (73.1) |
| PR-SMFRS ≥1-grade improvement, n (%) | 52 (46.8) | 156 (73.6) |
| CR-SMFRS ≥2-grade improvement, n (%) | 4 (3.6) | 82 (38.7) |
| PR-SMFRS ≥2-grade improvement, n (%) | 6 (5.4) | 70 (33.0) |
| SSRS responder, n (%) | 17 (15.3) | 125 (59.0) |
| SGQ responder, n (%) | ||
| 1 (fat under chin) | 10 (9.0) | 127 (59.9) |
| 2 (definition between chin and neck) | 11 (9.9) | 109 (51.4) |
| 3 (satisfaction with the treatment) | 26 (23.4) | 143 (67.5) |
| . | Placebo (n = 111) . | MEI005 (n = 212) . |
|---|---|---|
| CR-SMFRS ≥1-grade improvement, n (%) | 30 (27.0) | 155 (73.1) |
| PR-SMFRS ≥1-grade improvement, n (%) | 52 (46.8) | 156 (73.6) |
| CR-SMFRS ≥2-grade improvement, n (%) | 4 (3.6) | 82 (38.7) |
| PR-SMFRS ≥2-grade improvement, n (%) | 6 (5.4) | 70 (33.0) |
| SSRS responder, n (%) | 17 (15.3) | 125 (59.0) |
| SGQ responder, n (%) | ||
| 1 (fat under chin) | 10 (9.0) | 127 (59.9) |
| 2 (definition between chin and neck) | 11 (9.9) | 109 (51.4) |
| 3 (satisfaction with the treatment) | 26 (23.4) | 143 (67.5) |
CR-SMFRS, Clinician-Reported Submental Fat Rating Scale; PR-SMFIS, Patient-Reported Submental Fat Impact Scale; PR-SMFRS, Patient-Reported Submental Fat Rating Scale; SD, standard deviation; SMF, submental fat; SSRS, Subject Self-Rating Scale; SGQ, Subject Global Questions.
aThe reduction in SMF volume is at least 10% compared with the baseline.
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