Wave Life Sciences has begun dosing participants in the Phase 2a portion of its INLIGHT clinical trial evaluating WVE-007, an investigational obesity treatment designed to reduce body fat while preserving muscle
WVE-007 is a GalNAc-conjugated small interfering RNA therapy that silences INHBE messenger RNA. Wave said the program is supported by human genetic evidence and represents an approach to obesity that is distinct from incretin-based medicines
The Phase 2a study is enrolling participants in the United States and Europe with body mass index measurements between 35 and 50. The trial includes people with and without type 2 diabetes and is evaluating multiple doses of WVE-007
Participants will be monitored over 12 months through measurements that include body weight, waist circumference, body composition, liver fat, HbA1c, and lipid levels. Wave expects the findings to inform potential development in obesity, metabolic dysfunction-associated steatohepatitis, type 2 diabetes, and other cardiometabolic diseases
The program advanced after Phase 1 results showed reductions in total body fat, visceral fat, and waist circumference while preserving muscle. Wave said WVE-007 remained generally safe and well tolerated in the <a href="https://healthylife7.com/teaching-companies-to-tell-stories-with-data/” title=”Teaching Companies to Tell Stories With Data”>data reported to date
The Phase 1 portion evaluated otherwise healthy participants with an average body mass index of approximately 32, which was lower than the body mass index typically seen in later-stage obesity trials
Wave believes participants in the Phase 2a study may provide a clearer indication of WVE-007’s potential because they have higher body mass indexes and greater levels of adiposity
The company also believes the pharmacological profile observed to date could support dosing only once or twice per year. That would differentiate WVE-007 from frequently administered obesity medicines, although its dosing schedule, efficacy, and safety will require confirmation in larger clinical studies
Additional Phase 1 results, including data from the 600-milligram single-ascending-dose cohort, are expected during the second half of 2026
Wave is also positioning WVE-007 as a possible complement to incretin therapies rather than solely as a competing treatment
The company expects to begin separate Phase 2 studies during the second half of 2026 evaluating WVE-007 in combination with incretin medicines and as a maintenance treatment after patients discontinue incretins
These studies could help determine whether WVE-007 can support additional fat reduction, preserve muscle during weight loss, or help patients maintain improvements after ending incretin treatment. Those potential benefits have not yet been established in clinical trials
Beyond obesity, Wave is advancing WVE-006, an investigational RNA-editing treatment for alpha-1 antitrypsin deficiency. The company has scheduled a meeting with the U.S. Food and Drug Administration for the end of summer 2026 to discuss a potential accelerated approval pathway
WVE-006 is being developed to address both the lung and liver manifestations of alpha-1 antitrypsin deficiency by reducing mutant Z-AAT protein and increasing functional M-AAT protein. Wave said the treatment edits RNA without making permanent changes to DNA
The company is also advancing WVE-008 for liver disease associated with the PNPLA3 I148M genetic variant. A clinical trial application is expected during the second half of 2026
Wave reported $2.3 million in second-quarter revenue, compared with $8.7 million in the prior-year quarter. Research and development expenses increased to $51.3 million from $43.5 million, while general and administrative expenses rose to $24.8 million from $18 million
The company’s net loss widened to $69.4 million from $50.5 million. Wave ended June with $490.6 million in cash, cash equivalents, and marketable securities, compared with $602.1 million at the end of 2025
Wave expects its existing capital to fund operations into the third quarter of 2028. The estimate excludes potential future milestone and other payments under its collaboration with GSK
The advancement of WVE-007 into Phase 2a gives Wave an opportunity to test a differentiated obesity strategy centered on body composition rather than weight loss alone. The upcoming data will be important in determining whether the early findings involving fat reduction and muscle preservation can be reproduced in people with more severe obesity and related metabolic conditions
“Our second quarter performance reflects disciplined execution across the pipeline. We recently initiated dosing in the Phase 2a portion of our INLIGHT trial in obesity. Our Phase 1 clinical data have already demonstrated substantial reductions of fat – particularly harmful visceral fat – without muscle loss, and with the potential for once or twice-yearly dosing. We expect the Phase 2a portion of the INLIGHT trial, in individuals with higher BMI and higher body fat, to demonstrate WVE-007’s broad potential to deliver even greater fat loss and improvements in body composition, as well as benefits across additional cardiometabolic biomarkers such as liver fat. In tandem with this progress, we are working expeditiously to initiate Phase 2 trials evaluating WVE-007 in combination with incretins and as post-incretin maintenance; we believe WVE-007 has the potential to transform the current obesity treatment landscape.”
“In RNA editing, our RestorAATion-2 clinical data support WVE-006’s potential to offer a new standard of care for individuals living with AATD by treating both lung and liver manifestations of the disease, and restoring dynamic response of AAT protein, with convenient, infrequent subcutaneous dosing, and without the risks associated with DNA editing. We look forward to meeting with the FDA to discuss a pathway for accelerated approval for WVE-006. Building on our clinical success in RNA editing, WVE-008, our PNPLA3 RNA editing program, has the potential to address the nine million individuals living with this genetic liver disease. It’s exciting to see the clinical translation of our RNAi and RNA editing programs, enabled by our unique and proprietary chemistry, and supported by human genetics. We expect to provide further updates on our pipeline and platform innovations at our annual investor day this fall.”
Dr. Paul Bolno, MD, MBA, President and Chief Executive Officer at Wave Life Sciences
