Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eloralintide · 6 trials · 6 indications
Change from Baseline in the WOMAC Pain Subscale Score
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Eloralintide (YSA1) | EXPERIMENTAL | Participants will receive eloralintide subcutaneously (SC) |
| Placebo (YSA1) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide (YSA2) | EXPERIMENTAL | Participants will receive eloralintide SC |
| Placebo (YSA2) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide (YOA1) | EXPERIMENTAL | Participants will receive eloralintide subcutaneously (SC) |
| Placebo (YOA1) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide (YOA2) | EXPERIMENTAL | Participants will receive eloralintide SC |
| Placebo (YOA2) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide Dose 1 | EXPERIMENTAL | Participants will receive eloralintide subcutaneously (SC) |
| Eloralintide Dose 2 | EXPERIMENTAL | Participants will receive eloralintide SC |
| Eloralintide Dose 3 | EXPERIMENTAL | Participants will receive eloralintide SC |
| Eloralintide Dose 4 | EXPERIMENTAL | Participants will receive eloralintide SC |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| 1 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks. |
| 3 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 3 mg SC QW for 48 weeks. |
| 6 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 6 mg SC QW for 48 weeks. |
| 9 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 9 mg SC QW for 48 weeks. |
| 6/9 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks. |
| 3/6/9 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks. |
| Eloralintide (Reference) | ACTIVE_COMPARATOR | Participants will receive eloralintide reference formulation administered subcutaneously (SC). |
| Eloralintide (Test) | EXPERIMENTAL | Participants will receive eloralintide test formulation administered SC. |
| Eloralintide | EXPERIMENTAL | Eloralintide administered subcutaneously (SC) |
| Name | Type | Description |
|---|---|---|
| Eloralintide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Confirmed history of moderate-to-severe OSA * Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening * Have a BMI ≥27 kg/m2 at screening * Have a stable body weight (\<5% body weight change) for 90 days prior to screening * Have a history of at least one s...
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