RES-010 / Resalis Therap - LARVOL DELTA

Resalis Announces Initiation of Phase 1b Clinical Study Evaluating RES-010 as Treatment to Address Unmet Needs in Obesity (GlobeNewswire) - "The study will investigate the effect of RES-010 on body weight loss and other weight loss-related parameters, and evaluate safety, tolerability, and pharmacokinetics during 3 months of treatment in overweight and obese participants. The clinical study will be conducted at a single site in Australia, with topline data expected in late 2026....The Phase 1b trial is a randomized, placebo-controlled, sequential multiple ascending dose (MAD) study designed to enroll up to 36 healthy overweight and moderately obese adult participants in Australia. The trial includes up to three cohorts receiving once-weekly subcutaneous injections over a 12-week treatment period, with the option of a safety follow-up for up to 6 months."

First-in-human • P1 data • Trial status • Obesity

A trial to assess the safety, tolerability and efficacy of RES-010 in overweight and obese adults without obesity-related comorbidities. (ANZCTR) - P1 | N=36 | Not yet recruiting | Sponsor: Resalis Therapeutics Australia Pty Ltd

New P1 trial • Genetic Disorders • Obesity

RES-010-001: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE PHASE 1 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC, AND PHARMACODYNAMIC PROFILE OF RES-010 IN HEALTHY, OVERWEIGHT, AND MODERATELY OBESE SUBJECTS (clinicaltrialsregister.eu) - P1 | N=80 | Recruiting | Sponsor: Resalis Therapeutics S.r.l. | N=254 ➔ 80

Enrollment change • Genetic Disorders • Obesity

Targeting miR-22 for Sustained Weight Loss: Preclinical Translational Evidence for Obesity Therapy (OBESITY WEEK 2025) - "These findings support RES-010 as a first-in-class RNA-based therapy that reprograms adipose metabolism and has the potential to promote sustained weight loss. Preclinical and translational evidence, including data from human WAT organoids, strengthens its clinical relevance and supports its ongoing evaluation in phase 1 clinical trial as a disease-modifying approach for obesity."

Preclinical • Genetic Disorders • Metabolic Disorders • Obesity • MIR22

Resalis Therapeutics Reports Durable, Fat-Selective Weight Loss with RES-010 in Non-Human Primates at Multiple Scientific and Industry Meetings (GlobeNewswire) - "In this study, RES-010 demonstrated robust and durable weight reduction effects in obese NHPs maintained on a high-fat diet. After 10 weeks of treatment, RES-010 monotherapy achieved a 15% reduction in fat mass compared to semaglutide (16%), while also preserving lean mass (-1% with RES-010 versus -8% with semaglutide). In combination with semaglutide, RES-010 provided an additive benefit resulting in a 33% reduction of fat. Notably, after semaglutide interruption at week 10, the animals previously treated with the combination and still on RES-010 alone did not experience rebound weight gain despite a rapid increase in food intake....The ongoing Phase 1 trial (EUCT No.: 2024-514871-17-00) is designed to assess the safety, tolerability, and pharmacokinetic profile of RES-010 in the described population, with preliminary data expected in mid-2026."

P1 data • Preclinical • Obesity

‘Pioneering’ new weight-loss jab could help keep weight off even after you stop taking it (The Independent) - "In research presented at the annual meeting of the European Association for the Study of Diabetes, in Vienna, Austria, scientists found that when obese mice were given RES-010 they lost weight, despite eating the same amount as mice which were not given the treatment...Once the drug was stopped the mice did not regain weight, according to an abstract presented at the meeting....Another study looking into the safety of the jab in people is now in its early stages."

Preclinical • Obesity

Reprogramming obesity: preclinical development and phase 1 study design of RES-010, a novel miRNA-targeting therapy (EASD 2025) - "RES-010 demonstrates the ability to induce long-lasting weight loss in preclinical models, with effects sustained beyond treatment cessation. Its efficacy in NHPs under a fast-food diet and its ability to enhance the effects of GLP-1RA while allowing a less intensive dosing schedule support its potential as a transformative obesity therapy. The ongoing Phase 1 trial will also provide key translational insights, guiding further clinical development."

P1 data • Preclinical • Metabolic Disorders • Obesity • MIR22

Translatability of miR-22 Targeting in Restoring Metabolic Health (ADA 2025) - "By targeting miR-22, RES-010 reprograms adipose metabolism, promoting mitochondrial activation and WAT browning across obese mice, overweight non-human primates, and human adipose tissue models. These findings suggest that miR-22 inhibition may represent a novel therapeutic strategy to enhance metabolic flexibility."

Late-breaking abstract • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • MIR22

Promoting Superior Weight Loss with Lean Mass Preservation: RES-010 Enters Clinical Trials to Revolutionize Obesity Treatment (ECO 2025) - "In 3D human organoid models, it upregulated UCP1 and PGC1α, outperforming rosiglitazone in browning induction. RES-010 represents a significant advancement in obesity and MAFLD treatment by targeting miR-22, enhancing current therapies like GLP1-RA and overcoming their limitations. RES-010 benefits include preservation of lean mass and sustained metabolic improvements. The combination of Semaglutide and RES-010 represent a new therapeutic strategy: rapid induction weight loss with Semaglutide followed by long-term maintenance with RES-010 monotherapy."

Clinical • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus • MIR22

Resalis Therapeutics Announces Initiation of Phase 1 Clinical Trial for RES-010 in Obesity (Businesswire) - "Resalis Therapeutics...announced the initiation of its first-in-human, Phase 1 study for RES-010, a non-coding RNA-based compound designed to provide a disease-modifying approach to obesity treatment. Preclinical studies have demonstrated that RES-010 reduces fat mass, preserves lean body mass, and enhances energy expenditure. By targeting fat reduction across various regions of the body, including visceral and hepatic stores, RES-010 has the potential to complement existing therapies such as GLP-1 receptor agonists, and support sustainable, long-term weight management. The Phase 1 trial (EUCT No: 2024-514871-17-00) will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RES-010 in healthy, overweight, and moderately obese volunteers...Data from the combined SAD/MAD study, which involves multiple phases of dose escalation and extensive safety evaluation, are expected by mid-2026."

New P1 trial • P1 data • Obesity