Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LGD-6972 · 4 trials · 2 indications
AUC: ratio: medium test form to reference form
Cmax: ratio: medium test form to reference form
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 |
| Period 1 Treatment A | EXPERIMENTAL | Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted |
| Period 1 Treatment B | EXPERIMENTAL | Healthy subjects will receive a single dose orally of LGD-6972 solution fasted |
| Period 2 Treatment A | EXPERIMENTAL | Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted |
| Period 2 Treatment B | EXPERIMENTAL | Healthy subjects will receive a single dose orally of LGD-6972 solution fasted |
| 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 Solution | DRUG | 15 mg of LGD-6972 |
| LGD-6972 Capsules | DRUG | 15 mg LGD-6972 |
| 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...
LGD-6972 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus (T2DM). It is being studied in patients with Type 2 Diabetes Mellitus, and clinical trials have also included healthy subjects. The drug is administered orally and is currently in Phase 2 clinical development.
LGD-6972 is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LGND. Ligand is conducting clinical trials of LGD-6972 in the United States for the treatment of Type 2 Diabetes Mellitus.
LGD-6972 is in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug is investigational and has not been approved by regulatory authorities. It has completed Phase 1 and Phase 2 trials, with a total of three completed clinical studies involving 252 participants.
LGD-6972 has been studied in three completed clinical trials in the United States. These include NCT01919684 and NCT02250222, both Phase 1 studies in healthy subjects and patients with Type 2 Diabetes Mellitus, and NCT02672839, a Phase 1 bioavailability study. A Phase 2 trial, NCT02851849, enrolled 148 patients with Type 2 Diabetes Mellitus.
Yes, LGD-6972 has been evaluated in randomized, double-blind, placebo-controlled clinical trials. The Phase 2 study NCT02851849 used a placebo control to assess the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus. All completed trials were conducted in the United States.