Radella Pharmaceuticals has reported promising results from its Phase 1b clinical trial of MD-18, a novel obesity treatment that achieved significant weight loss alongside broad cardiometabolic improvements. The double-blind, placebo-controlled study with ascending dosage demonstrated a 2.7% weight loss in healthy participants over 28 days without titration, conducted at the Sheba Medical Center in Israel.
Novel Mechanism Targets Metabolic Signaling
MD-18 represents a first-in-class peptide that employs a dual-pronged approach to weight management by escalating insulin sensitivity while increasing energy expenditure through reactivation of leptin signaling. The drug works through precise modulation of PTP1B enzymes, which are often hindered by obesity. According to Radella, MD-18 encourages the body to burn calories already stored within the body, leading to desired weight loss results while maintaining lean muscle mass.
"These data validate MD-18 as a next-generation approach to cardiovascular and metabolic health," said Daniel Cohen, founder and chief executive officer of Radella. "Participants lost weight and waist circumference and saw improvements in cholesterol and insulin measures. These findings indicate that MD-18 may offer pan-cardiometabolic benefits for common obesity co-morbidities, including heart disease and diabetes."
Comprehensive Cardiometabolic Benefits
Beyond weight reduction, the Phase 1b trial revealed multiple cardiometabolic improvements. Trial data showed MD-18's potential to sustainably reduce adipose tissue loss while simultaneously retaining lean muscle mass, distinguishing it from other GLP-1 receptor agonists that focus on weight reduction through appetite suppression and are commonly linked to decreases in lean muscle mass.
The study demonstrated MD-18's ability to lower LDL cholesterol levels in patients and significantly decrease levels of alanine aminotransferase compared to placebo, suggesting the drug's potential to decrease liver fat. These results address broader health concerns associated with obesity, as upwards of two-in-five American adults suffer from obesity while also being diagnosed with additional chronic conditions such as high blood pressure, heart disease, and diabetes.
Safety Profile and Tolerability
The trial maintained a clean safety profile, with all drug-related adverse events listed as mild (Grade 1). Most gastrointestinal events showed similarities between the placebo and MD-18 groups, indicating favorable tolerability compared to other obesity treatments that commonly face tolerability concerns.
Expansion Plans
Following these Phase 1b results, Radella expects to initiate an additional two cohorts into its intent-to-treat population. The expanded trials will include patients without type 2 diabetes, patients who are overweight, and patients who are overweight and diagnosed with type 2 diabetes. These upcoming studies will administer participants with placebo or a single weekly injection of MD-18 over 12-week periods, representing a significant extension from the initial 4-week trial duration.
