Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-0976 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 50 mg GS-0976 (Cohort 1) | EXPERIMENTAL | Sequence 1: Period 1 (2 days): 50 mg (1 x 50 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 2: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 50 mg (1 x 50 mg capsule) + IV infusion 1-13C acetate and fructose solution |
| 200 mg GS-0976 (Cohort 2) | EXPERIMENTAL | Sequence 3: Period 1 (2 days): 200 mg (1 x 200 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 4: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 200 mg (1 x 200 mg capsule) + IV infusion 1-13C acetate and fructose solution |
| 20 mg GS-0976 (Cohort 3) | EXPERIMENTAL | Sequence 5: Period 1 (2 days): 20 mg (2 X 10 mg capsule) + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): placebo + IV infusion 1-13C acetate and fructose solution Sequence 6: Period 1 (2 days): placebo + IV infusion 1-13C acetate and fructose solution; Washout Period (minimum of 5 days); Period 2 (2 days): 20 mg (2 X 10 mg capsule) + IV infusion 1-13C acetate and fructose solution |
| Name | Type | Description |
|---|---|---|
| GS-0976 | DRUG | Capsule(s) administered orally |
| Placebo | DRUG | Capsule(s) administered orally |
| 1-13C acetate | OTHER | 10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours |
| Fructose solution | OTHER | Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses |
Inclusion Criteria: * Overweight and/or obese, but otherwise healthy males * Weight ≥ 50.0 kg * Body Mass Index (BMI): 25.0 - 32.0 kg/m\^2, inclusive Exclusion Criteria: * Intolerance to or malabsorption of fructose * A history of clinically significant gastrointestinal disease and/or surgery, wh...
GS-0976 is an investigational small molecule being studied for its pharmacodynamic effects on fractional de novo lipogenesis (DNL). It was evaluated in a Phase 1 clinical trial in healthy adult subjects to assess the effects of a single oral dose on this metabolic pathway.
GS-0976 is being developed by Gilead Sciences, Inc., which is publicly traded under the ticker symbol GILD on the NASDAQ stock exchange.
GS-0976 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities and is still undergoing clinical evaluation.
GS-0976 has been studied in one completed Phase 1 clinical trial, identified as NCT02876796. This trial evaluated the pharmacodynamic effects of a single oral dose of GS-0976 in healthy adult subjects, with a total enrollment of 30 participants.
Yes, GS-0976 is also known as NDI-010976. The clinical trial NCT02876796 refers to the drug as GS-0976 (NDI-010976), indicating that these names are used interchangeably for the same investigational compound.