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Also known as LGD-6972 Solution, LGD-6972 sodium oral solution
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 studied for the treatment of Type 2 Diabetes Mellitus. It has been evaluated in four completed clinical trials, including a Phase 2 study in patients with Type 2 Diabetes Mellitus and three Phase 1 studies. It is not approved for any indication.
LGD-6972 is being developed by Ligand Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker LGND. The company has sponsored all four of the drug's completed clinical trials, which were conducted in the United States.
LGD-6972 has completed Phase 2 development. Its most advanced trial, NCT02851849, was a Phase 2 study in patients with Type 2 Diabetes Mellitus that enrolled 148 participants. Three additional Phase 1 trials have also been completed. No trials are currently active.
LGD-6972 has been studied in four completed trials: NCT02851849, a Phase 2 study in Type 2 Diabetes Mellitus; NCT02672839, a Phase 1 bioavailability comparison of capsule and oral solution formulations; NCT02250222, a Phase 1 safety and tolerability study; and NCT01919684, a Phase 1 study of safety, tolerability, pharmacokinetics and pharmacodynamics.
Yes. LGD-6972 Solution and LGD-6972-5 mg are alternative names for LGD-6972. The solution form refers to an oral liquid formulation that was compared with a capsule formulation in a Phase 1 bioavailability study, NCT02672839.
LGD-6972 trials were randomized, double-blind, and placebo-controlled, with a total enrollment of 264 participants across four completed studies. Participants were 21 years of age or older, and the trials were conducted in the United States. The Phase 2 trial enrolled patients with Type 2 Diabetes Mellitus.