Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02851849 | A Study of LGD-6972 in Patients With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 148 | — | — | Sep 1, 2016 | Jun 1, 2017 | Jan 12, 2018 | 29 | United States |
| NCT02250222 | Safety and Tolerability Study of Oral LGD-6972 for Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2014 | Jun 1, 2015 | Jun 11, 2015 | 3 | United States |
| NCT01919684 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LGD-6972 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 56 | — | — | Nov 1, 2013 | Mar 1, 2014 | Sep 25, 2014 | 1 | United States |
Safety and tolerability of repeat (14 days for normoglycemic healthy subjects (NHS) and 14 days for type 2 diabetes mellitus (T2DM) subjects) and sequential increasing oral doses of LGD-6972 in NHS and subjects withT2DM will be compared to NHS and T2DM subjects receiving placebo.
Subjects in Groups A,B,C,D,E and F will be admitted to the study site on Day -1, and Group G will be admitted to the study site on Day -2. Each subject will be administered a specified dose of LGD-6972 or placebo under fasting conditions (and fed conditions for Group D to evaluate the effects of food on the LGD-6972 PK profile)and will be observed through the morning of Day 3 (48 hour post dose assessment). Safety assessments, LGD-6972 PK sample collection, and PD assessments will occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Day 7 for a follow up evaluation.
| Arm | Type | Description |
|---|---|---|
| LGD-6972-5 mg | ACTIVE_COMPARATOR | 5 mg LGD-6972 QD |
| LGD-6972-10 mg | ACTIVE_COMPARATOR | 10 mg LGD-6972 QD |
| LGD-6972-15 mg | ACTIVE_COMPARATOR | 15 mg LGD-6972 QD |
| Placebo | PLACEBO_COMPARATOR | Placebo QD |
| Part 1: LGD-6972 15 mg | EXPERIMENTAL | 15 mg LGD-6972 administered once daily (QD) for 14 days. |
| Part 1: Placebo (Captisol ®) | PLACEBO_COMPARATOR | Placebo administered once daily (QD) for 14 days. |
| Part 2: LGD-6972 5 mg | EXPERIMENTAL | 5 mg LGD-6972 administered orally QD for 14 days. |
| Part 2: LGD-6972 10 mg | EXPERIMENTAL | 10 mg LGD-6972 administered orally QD for 14 days. |
| Part 2: LGD-6972 15 mg | EXPERIMENTAL | 15 mg LGD-6972 administered orally QD for 14 days. |
| Part 2: Placebo (Captisol ®) | PLACEBO_COMPARATOR | Placebo administered orally QD for 14 days. |
| Active | ACTIVE_COMPARATOR | LGD-6972 |
| Placebo (Captisol®) | PLACEBO_COMPARATOR | Vehicle Control (Captisol®) |
| Name | Type | Description |
|---|---|---|
| LGD-6972-5 mg | DRUG | 5 mg LGD-6972 QD |
| LGD-6972-10 mg | DRUG | 10 mg LGD-6972 QD |
| LGD-6972-15 mg | DRUG | 15 mg LGD-6972 QD |
| Placebo | OTHER | Placebo QD |
| LGD-6972 | DRUG | LGD-6972 sodium salt powder in Captisol ® (betadex \[β-cyclodextrin\] sulfobutylether sodium, NF) |
| Placebo (Captisol ®) | DRUG | betadex \[β-cyclodextrin\] sulfobutylether sodium, NF |
| Placebo (Captisol®) | DRUG | - |
Inclusion Criteria: 1. Female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy or bilateral tubal ligation), or naturally post-menopausal for at least 12 months and with a follicle stimulating hormone (FSH) level in the post-menopausal range (if not taking hormone replace...