Wave Life Sciences Ltd. (NASDAQ:WVE) on Monday shared interim data from the lowest therapeutic cohort of the ongoing first-in-human INLIGHT trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA using Wave’s proprietary SpiNA design, for obesity.
A single 240 mg dose of WVE-007 led to an improvement in body composition characterized by reductions in total and visceral fat mass at three months and an increase in lean mass.
The INLIGHT clinical trial is a Phase 1 study of otherwise healthy individuals living with overweight or obesity, BMI between 28 and 35 kg/m2, and HbA1c of less than 5.9.
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The study does not include any diet or exercise modifications. As of the data cut-off date, INLIGHT has enrolled over 100 individuals.
The update includes the three-month follow-up from the single subcutaneous 240 mg dose cohort in 32 individuals with an approximate mean baseline BMI of 32 kg/m2.
“The data indicate meaningful reductions in body fat, particularly targeting harmful visceral fat, while preserving lean mass,” said Angela Fitch, MD, FACP, co-founder and Chief Medical Officer at knownwell, former co-director of the Massachusetts General Hospital Weight Center, faculty at Harvard Medical School, and former president of the Obesity Medicine Association.
From baseline, a single dose of WVE-007 improved body composition and led to a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body fat (3.5 lbs; p=0.07), and a 3.2% increase in lean mass (4.0 lbs; p=0.01).
No statistically significant changes from baseline in these parameters were observed in the placebo group (0.2% reduction in visceral fat, 0.5% reduction in total body fat, 2.3% increase in lean mass).
From the perspective of change in body weight (or total mass) from baseline, the loss of total fat was offset by the gain in lean mass (primarily consisting of muscle) at this interim assessment in this patient population.
When adjusting for placebo, a single dose of WVE-007 led to a 9.2% reduction in visceral fat, a 4.0% reduction in total fat mass, a 0.9% increase in lean mass, and a 0.9% decrease in total mass from baseline.
Consistent and durable serum Activin E reductions continue to be observed across participants and support WVE-007’s potential for once or twice-yearly dosing.
Maximum reductions in serum Activin E of 78% were observed 43 days post a single 240 mg dose. Mean reductions of greater than 75% were maintained at least up to Day 85, the end of the current data cut.
WVE-007 continues to be generally safe and well-tolerated to date up to 600 mg. There were no discontinuations, and no severe or serious treatment-emergent adverse events (TEAEs).
All TEAEs were mild or moderate, and all treatment-related adverse events were mild.
The INLIGHT clinical trial is ongoing with the 240 mg (n=32), 400 mg (n=32), and 600 mg (n=32) cohorts fully dosed.
In the first quarter of 2026, Wave expects to deliver further follow-up (six-month) data from the 240 mg single-dose cohort, as well as three-month follow-up data from the 400 mg single-dose cohort.
In the second quarter of 2026, Wave expects to deliver six-month follow-up data from the 400 mg single-dose cohort and three-month follow-up data from the 600 mg single-dose cohort.
The company is planning for Phase 2 trials evaluating WVE-007 both as a monotherapy and an add-on therapy to incretins in populations with higher BMI and related co-morbidities, and as maintenance post-incretin treatment.
WVE Price Action: WAVE Life Sciences shares were up 133.78% at $17.51 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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