TRYNGOLZA demonstrated a well-tolerated safety profile in participants with severe hypertriglyceridemia (sHTG)1
Most injection-site reactions were mild. None were severe.2
with TRYNGOLZA than with placebo1†
| TRYNGOLZA 50 mg (n=354) | TRYNGOLZA 80 mg (n=351) | Placebo (n=356) | |
|---|---|---|---|
Injection-site reactions | 43 (12%) | 64 (18%) | 8 (2%) |
Transaminases increased | 11 (3%) | 14 (4%) | 2 (1%) |
- The safety of TRYNGOLZA was evaluated in 705 patients (50 mg pooled n=354; 80 mg pooled n=351) who received at least 1 dose of treatment and in 356 who received placebo1
- Adverse reactions led to discontinuation of treatment in 5% of TRYNGOLZA-treated patients and 2% of placebo-treated patients1
- The most common adverse reaction for TRYNGOLZA treatment discontinuation was injection-site reactions1
CORE-OLE is an open-label extension study continuing to evaluate the safety and tolerability of TRYNGOLZA in patients with sHTG.3
*Grouped terms composed of several similar terms.1
†Pooled analysis of CORE and CORE2.1
sHTG=severe hypertriglyceridemia.
Laboratory tests1
Decrease in platelet count: TRYNGOLZA can cause reductions in platelet count. Across all trials (Balance, CORE, and CORE2), mean decreases from baseline through Week 53 ranging from 6% (50 mg, CORE and CORE2) to 10% (80 mg, across all trials) were observed in TRYNGOLZA-treated patients, whereas placebo-treated patients showed an increase of 22% in Balance or no change in CORE and CORE2. The proportion of patients experiencing a bleeding adverse event was similar between the TRYNGOLZA and placebo groups. There were no major bleeding events associated with low platelet counts.
Increase in glucose: Increases in average values in fasting glucose (≤17 mg/dL) and HbA1c (<0.2 percentage points) were observed over time with TRYNGOLZA treatment in the FCS population in Balance. The incidence of hyperglycemia (defined as adverse events, new antidiabetic medication, or laboratory values) was higher in patients with FCS treated with TRYNGOLZA without a medical history of diabetes at baseline (52%) compared with placebo-treated patients (35%).
In CORE and CORE2, increases in average values in fasting glucose (≤9 mg/dL) and HbA1c (<0.3 percentage points) were observed over time in the sHTG population treated with TRYNGOLZA. These increases were more pronounced in patients with a history of diabetes at baseline; however, increases in fasting glucose and HbA1c were also observed more frequently with TRYNGOLZA compared with placebo in patients without a history of diabetes at baseline.
Increase in liver enzymes: Mean liver enzyme values increased from baseline with TRYNGOLZA treatment but remained within the normal range. These increases occurred within the first 6 months of treatment and stabilized. However, when evaluating any liver enzyme increase in patients with sHTG, increases in liver enzymes greater than or equal to 3 times the upper limit of normal were reported more frequently with TRYNGOLZA 80 mg (7%) compared with TRYNGOLZA 50 mg (3%) and placebo (3%). Liver enzymes returned toward baseline with discontinuation of TRYNGOLZA.
Increase in hepatic fat fraction (HFF): HFF was assessed in patients with sHTG in a substudy within CORE and CORE2. Mean HFFs were elevated at baseline (17% TRYNGOLZA 50 mg, 14% TRYNGOLZA 80 mg, 14% placebo). Dose-dependent changes in HFF at 12 months of treatment were a mean increase of 2 percentage points in the TRYNGOLZA 50 mg group and 4 percentage points in the TRYNGOLZA 80 mg group vs 0 percentage points in the placebo group. The clinical meaningfulness of these findings remains uncertain.
Increase in low-density lipoprotein cholesterol (LDL-C): In all trials (Balance, CORE, and CORE2), increases were observed in LDL-C in TRYNGOLZA-treated patients compared with placebo. These increases were accompanied by decreases in non–high-density lipoprotein cholesterol (non–HDL-C). Among patients with FCS, total apolipoprotein B (apoB) increased, whereas among patients with sHTG, apoB decreased.
Balance, CORE, and CORE2 are referred to as Trial 1, Trial 2, and Trial 3, respectively, in the full Prescribing Information.1
FCS=familial chylomicronemia syndrome; HbA1c=hemoglobin A1c.