Gym haters, rejoice — the workout of the future may not require breaking a sweat.
Biotech company Enveda announced this week that its experimental drug, designed to curb appetite and mimic some of the body’s effects of physical activity, delivered encouraging results in its first clinical trial.
“ENV-308 is our attempt to put the chemistry of exercise into a daily tablet,” Viswa Colluru, the startup’s founder and CEO, said in a statement.
The pill mimics a molecule called lactate phenylalanine, or Lac-Phe, which scientists at Stanford discovered in 2022.
The body produces it naturally when lactate — a chemical released by muscles during vigorous exercise — combines with the amino acid phenylalanine.
Once it enters the bloodstream, Lac-Phe acts sends a signal to the brain to dial down the drive to eat. Studies in animals have also found that it can suppress appetite and reduce obesity.
There’s just one catch: Lac-Phe breaks down quickly, so it doesn’t stay in the bloodstream long enough to keep the urge to eat at bay throughout the day and promote lasting weight loss.
That’s where ENV-308 comes in. Enveda’s pill aims to harness Lac-Phe’s benefits in a daily oral tablet, potentially making them last longer.
In a Phase 1 clinical trial, Enveda gave ENV-308 at varying strengths to 88 healthy adults. Notably, the experiment didn’t set out to determine whether the drug actually helped with weight loss. Instead, researchers were primarily looking at whether it was safe.
They found that the participants tolerated the drug across the full range of doses tested, with the company reporting it had an “exceptional gastrointestinal safety profile.”
That could be a big deal in the weight-loss-drug world.
Nausea, vomiting and other gastrointestinal problems are among the most common reasons people stop taking GLP-1s, the blockbuster class of medications that includes medications such as Ozempic and Wegovy.
In animal studies, ENV-308 also preserved lean muscle mass during weight loss. That’s significant because research suggests that some of the pounds people lose while taking GLP-1s can come from muscle, not just fat.
Animals also maintained their slimmer figures after scientists stopped giving them ENV-308. That could be particularly important, since many people who stop taking GLP-1 drugs regain some of the weight they lost — and sometimes even more.
“Patients and physicians need therapies that sustain metabolic benefit over time,” said Dr. Naveed Sattar, a professor of metabolic medicine at the University of Glasgow and chair of the UK’s Obesity Healthcare Goals Program.
“ENV-308 represents a novel approach targeting this challenge, and it is encouraging to see early clinical data from a new mechanism of action supporting its progression into later-stage clinical trials.”
Still, don’t expect ENV-308 to send Ozempic packing just yet.
Enveda says the pill could potentially be used alongside existing therapies like GLP-1s, including possibly allowing them to be taken less frequently. The company is also exploring whether the approach could help avoid some of the side effects associated with the treatments.
The Phase I trial also looked at leptin, a hormone that helps regulate hunger. People with obesity often have high leptin levels but can become resistant to its signals.
Early results suggest that ENV-308 lowers leptin levels in animals and humans, with the biggest drops seen in participants who started with the highest levels.
“There is now compelling data in preclinical models indicating that Lac-Phe is involved in regulating several aspects of metabolic, brain, and inflammatory health,” said Dr. Jonathan Long, a leading researcher in exercise metabolism and advisor to Enveda.
“The possibility that ENV-308 may mimic these effects in a daily oral tablet in humans is an extremely exciting potential scientific breakthrough.”
In the next round of trials, researchers will look at whether ENV-308 can actually affect body weight and composition, as well as leptin biology and other markers of metabolic health. They’ll also study how the drug interacts with GLP-1 medications.
But Enveda isn’t stopping at weight loss.
The company also plans to study whether ENV-308 could help treat other conditions where exercise may be beneficial, including migraines, inflammatory bowel disease and polyendocrine metabolic ovarian syndrome (PMOS), formerly known as polycystic ovary syndrome.
But don’t expect to get a prescription anytime soon. ENV-308 is still in the early stages of development, and it will take years to determine whether it works and is safe for long-term use.
Even if those trials succeed, the pill would still need approval from the Food and Drug Administration before it could become available to the public.
If it does reach the market, don’t cancel your gym membership just yet. While ENV-308 aims to mimic some of the effects of exercise, working out does a lot more than burn calories.
Physical activity can improve mental health, support brain function, promote better sleep, boost energy, reduce inflammation, strengthen the immune system and support a healthy gut — benefits you’ll still need to break a sweat to get.
