Investigational Ketogenic Diet Pill BL-001 Shows Significant Weight Loss in Phase 1 Trial
Overweight individuals in the highest dose group with weight loss at day 28 continued to lose weight at the 2-week follow-up, with metabolic changes mimicking ketogenic effects.
Bloom Science’s investigational antiobesity drug, BL-001, demonstrated statistically significant weight loss in overweight individuals during a phase 1 clinical trial, the company announced. The randomized, double-blind, placebo-controlled trial assessed BL-001’s safety, tolerability, pharmacokinetics, and pharmacodynamics over a 28-day period in 32 healthy and overweight adults.
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The oral therapy is designed to replicate the metabolic effects of the ketogenic diet, according to the Bloom Science announcement.
The overall treatment effect of BL-001 on weight loss was statistically significant (P =.0424; mixed model repeated measures) with overweight participants experiencing a placebo-adjusted mean weight reduction of 2.3% (P =.001). The percent weight change between overweight and healthy-weight individuals treated with BL-001 was also statistically significant (P =.0003), with the highest recorded weight loss reaching 4.9% of body weight.
Notably, 80% of participants who lost weight on BL-001 maintained their weight loss 2 weeks after their last dose. Among overweight subjects receiving the highest dose, 100% continued losing weight, with an average 3.4% reduction at the follow-up assessment.
Study findings for the potentially first-in-class Live Biotherapeutic Product indicate dose-dependent metabolic shifts, including urinary ketone production, appetite reduction, and statistically significant changes in metabolic hormones involved in appetite control, metabolic regulation, and digestion. Results of a larger metabolomics analysis showed statistically significant changes in circulating ketone bodies, all effects not observed in the placebo group, according to the company.
Bloom Science said that the clinical data on these potential effects support advancing BL-001 into a phase 2 trial in adults with obesity in 2026.
“We believe BL-001 represents a groundbreaking approach to obesity treatment, with the potential to address the limitations of existing therapies by offering a safer, naturally inspired, multi-pathway solution,” Louis Licamele, PhD, chief development officer of Bloom Science, said in the news release. “We are excited by the current data and remain dedicated to developing a more patient-friendly alternative to current treatments that can provide sustainable weight loss while improving long-term compliance and outcomes.”
BL-001has previously shown efficacy in preclinical models of epilepsy, demonstrating modulation of gamma-aminobutyric acid (GABA) and bioenergetic pathways associated with seizure suppression. The company is also exploring the drug’s potential application in Dravet syndrome and other developmental and epileptic encephalopathies.
“While the ketogenic diet has long been known for its therapeutic effects, BL-001’s potential to replicate its benefits in a more tolerable form of daily oral capsules opens exciting possibilities for patients,” Christopher Reyes, PhD, Bloom Science chief executive officer, said. “This validation supports our continued clinical efforts targeting both obesity and Dravet Syndrome.”
Several theories have been advanced as to why the ketogenic diet promotes weight loss2:
- A satiating effect with decreased food cravings due to the high-fat content of the diet.
- A decrease in appetite-stimulating hormones, such as insulin and ghrelin, when eating restricted amounts of carbohydrate.
- A direct hunger-reducing role of ketone bodies—the body’s main fuel source on the diet.
- Increased calorie expenditure due to the metabolic effects of converting fat and protein to glucose.
- Promotion of fat loss versus lean body mass, partly due to decreased insulin levels.
