Resalis Therapeutics has announced the commencement of its first-in-human Phase 1 clinical trial for RES-010, a compound based on non-coding RNA aimed at providing a disease-modifying strategy for obesity treatment. Preclinical research has shown that RES-010 effectively reduces fat mass, maintains lean body mass, and boosts energy expenditure. 

By focusing on fat reduction in various body areas, including visceral and hepatic fat stores, RES-010 has the potential to enhance existing treatments like GLP-1 receptor agonists and promote sustainable, long-term weight management. The Phase 1 trial (EUCT No: 2024-514871-17-00) will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RES-010 in healthy individuals who are overweight or moderately obese.

"The launch of our Phase 1 trial for RES-010 represents a pivotal moment in our efforts to tackle the intricate biological factors contributing to obesity. By targeting the miR-22 pathway, a crucial metabolic regulator, RES-010 aims to selectively diminish fat while safeguarding muscle mass. This innovative mechanism may enhance and prolong the effectiveness of existing obesity therapies," stated Almut Nitsche, Chief Medical and Development Officer of Resalis Therapeutics. "This trial is a vital step in translating our preclinical findings into clinical progress, setting the stage for a new era of long-term obesity management solutions."

"Resalis has reached the clinical development phase for RES-010 following comprehensive preclinical assessments and a profound understanding of metabolic disorders, the non-coding RNA field, and RNA-based therapies. With RES-010, we aim to transition from merely managing short-term symptoms to achieving lasting, impactful results in obesity treatment," remarked Alessandro Toniolo, Chief Executive Officer of Resalis Therapeutics. "Through this trial, we are dedicated to validating our approach and advancing toward a transformative solution for individuals affected by metabolic diseases."

The Phase 1 trial is a randomized, double-blind, placebo-controlled study taking place in the Netherlands. It is divided into two segments: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. During the SAD phase, up to 48 healthy male and female participants will receive increasing single doses of RES-010 to assess its safety and pharmacokinetics. The following MAD phase will include 24 overweight and 8 moderately obese participants who will be administered multiple doses to further evaluate the safety and tolerability of RES-010.

The main goal of the trial is to determine the safety and tolerability of RES-010, alongside an evaluation of its pharmacokinetic profile. Additionally, exploratory endpoints will focus on the impact of RES-010 on specific metabolic markers, changes in lipid metabolism, body weight, appetite, and glucose tolerance. Results from the combined SAD/MAD study, which encompasses various phases of dose escalation and thorough safety assessments, are anticipated by mid-2026.