TRYNGOLZA 80 mg was studied in familial chylomicronemia (FCS)—the most severe form of severe hypertriglyceridemia (sHTG)1-3
The Balance trial was a randomized, placebo-controlled, double-blind, phase 3 clinical trial in 45 adults with FCS.1,2
Participants were randomized to receive TRYNGOLZA 80 mg or placebo once every 4 weeks for 6 months* for the primary analysis, and were continued over a 12-month† treatment period.1,4
- Fasting triglyceride levels ≥880 mg/dL1
- Genetically identified FCS based on variants in genes known to cause complete or partial deficiency in LPL function.‡ Participants with indeterminate genetic test results were confirmed to have FCS through adjudication by subject matter expert.1,2,4
- ≥4-week run-in period during which patients followed a low-fat diet of ≤20 grams of fat per day1
- Mean percent change in fasting triglycerides from baseline to Month 6* compared with placebo1
- Mean percent change in fasting triglycerides from baseline to Month 12 compared with placebo2,4
- Adjudicated pancreatitis events and number of participants affected during treatment period2,4
*Average of Weeks 23, 25, and 27.1
†Average of Weeks 51 and 53.4
‡Variants were LPL, APOA5, GPIHBP1, LMF1, or APOC2.2
APOA5=apolipoprotein A5; APOC2=apolipoprotein C2; GPIHBP1=glycosylphosphatidylinositol-anchored high-density lipoprotein binding protein 1; LMF1=lipase maturation factor 1; LPL=lipoprotein lipase.
Participant demographic and baseline characteristics were generally similar across treatment groups1§
| Baseline characteristic | TRYNGOLZA 80 mg (n=22) | Placebo (n=23) |
|---|---|---|
| Body mass index (kg/m2; mean±SD) | 25.1±6.0 | 24.2±4.1 |
| History of acute pancreatitis in the prior 10 years | 17 (77%) | 15 (65%) |
| Type 1 or 2 diabetes | 7 (32%) | 6 (26%) |
| Hypertension | 4 (18%) | 6 (26%) |
| Triglyceride level (mg/dL; mean±SD) | 2613±1499 | 2596±1256 |
| apoC-III level (mg/dL; mean±SD) | 27.5±11.6 | 27.7±11.7 |
| Non-HDL cholesterol level (mg/dL; mean±SD) | 262.9±100.4 | 271.3±113.3 |
§Abbreviated baseline characteristics table.2
apoC-III=apolipoprotein C-III; non–HDL=non–high-density lipoprotein; SD=standard deviation.
TRYNGOLZA is the only therapy included in the ACC/AHA Guideline for the treatment of FCS5
The 2026 ACC/AHA Guideline on the Management of Dyslipidemia includes a Class 1 (strong) recommendation for TRYNGOLZA 80 mg for adults with FCS and fasting triglycerides ≥1000 mg/dL (11.3 mmol/L), as an adjunct to diet, to lower triglyceride levels and reduce risk of pancreatitis.5
ACC=American College of Cardiology; AHA=American Heart Association.