Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SCH 497079 · 2 trials · 4 indications
Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.
Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.
| Arm | Type | Description |
|---|---|---|
| SCH 497079 | EXPERIMENTAL | SCH 497079, administered orally, once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules, administered orally, once daily |
| Treatment sequence 1: SCH 497079 → Placebo → Metformin | EXPERIMENTAL | Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks. |
| Treatment sequence 2: Placebo → Metformin → SCH 497079 | EXPERIMENTAL | Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks. |
| Treatment sequence 3: Metformin → SCH 497079 → Placebo | EXPERIMENTAL | Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks. |
| Treatment sequence 4: SCH 497079 → Metformin → Placebo | EXPERIMENTAL | Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks. |
| Treatment sequence 5: Placebo → SCH 49709 → Metformin | EXPERIMENTAL | Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks. |
| Treatment sequence 6: Metformin → Placebo → SCH 497079 | EXPERIMENTAL | Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| SCH 497079 | DRUG | 100 mg capsule administered orally |
| Placebo | DRUG | Placebo capsules matching SCH 497079 administered orally |
| Metformin | DRUG | Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose) |
Inclusion Criteria: * \>= 18 years of age, of either sex, and of any race. * Obese or overweight participants. Exclusion Criteria: * Participants who have a history of major eating disorders, gastrointestinal (GI) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectiou...
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SCH 497079 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus, Obesity, and overweight conditions. It is in Phase 2 clinical development for these metabolic indications.
SCH 497079 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK.
SCH 497079 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It has completed a Phase 2 trial in obesity and overweight participants.
SCH 497079 has been studied in clinical trials including NCT00642993, a Phase 2 trial in obesity and overweight participants, and NCT00673465, a Phase 1 trial in Type 2 Diabetes Mellitus. Both trials are completed.
SCH 497079 is the drug studied in the trial identified as P05483, which is the study number for the Phase 2 trial NCT00642993. This trial evaluated the effect of SCH 497079 on weight in obese and overweight participants.