| Primary | Change From Baseline in Body Weight | | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight measurements at Baseline and on Week 26. | Posted | | Least Squares Mean | Standard Error | kg | | Baseline Day 1 and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Miricorlilant 600 mg | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing | | OG001 | Miricorlilant 900 mg | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing | | OG002 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. Placebo: Placebo for oral dosing |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.41± 0.644
- OG001-0.91± 0.631
- OG002-1.66± 0.644
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | 0.7870 | | Least Squares Mean Difference | 0.24 | | | 2-Sided | 95 | -1.52 | 2.01 | | | | | Superiority | | | | | Mixed Models Analysis | | 0.4018 |
|
| Secondary | Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo | | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight measurements at Baseline and on Week 26. | Posted | | Least Squares Mean | Standard Error | kg | | Baseline Day 1 and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Miricorilant 600 mg or 900 mg | Patients who meet the entry criteria will be randomized to receive miricorilant 600 mg (4 X 150 mg) tablets or 900 mg (6 X 150 mg) tablets orally once-daily for 26 weeks. | | OG001 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. |
| |
| Secondary | Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo | Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had Baseline and ≥1 body weight measurement on or after Week 4. | Posted | | Count of Participants | | Participants | | Baseline Day 1 to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Miricorlilant 600 mg | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing | | OG001 | Miricorlilant 900 mg | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing | | OG002 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. Placebo: Placebo for oral dosing |
| |
| Secondary | Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo | | The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had weight and hip measurements at Baseline and on Week 26. | Posted | | Least Squares Mean | Standard Error | Ratio | | Baseline Day 1 and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Miricorlilant 600 mg | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing | | OG001 | Miricorlilant 900 mg | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing | | OG002 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. Placebo: Placebo for oral dosing |
| |
| Other Pre-specified | Number of Patients With One or More Treatment-emergent Adverse Events | | The Safety Population was patients who received ≥1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline Day 1 to Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Miricorlilant 600 mg | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing | | OG001 | Miricorlilant 900 mg | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing | | OG002 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. Placebo: Placebo for oral dosing |
| |
| Other Pre-specified | Number of Patients With One or More Treatment-emergent Serious Adverse Events | | The Safety Population was patients who received ≥1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline Day 1 to Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Miricorlilant 600 mg | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing | | OG001 | Miricorlilant 900 mg | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing | | OG002 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. Placebo: Placebo for oral dosing |
| |
| Other Pre-specified | Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation | | The Safety Population was patients who received ≥1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline Day 1 to Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Miricorlilant 600 mg | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing | | OG001 | Miricorlilant 900 mg | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing | | OG002 | Placebo | Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks. Placebo: Placebo for oral dosing |
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