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Life sciences · Journal article
Diabetes Obesity and Metabolism · October 14, 2026
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ABSTRACT Aim This Phase 1 program evaluated the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of the novel melanin‐concentrating hormone receptor‐1 antagonist RGH‐706. Methods Study A was a first‐in‐man, randomized trial comprising a double‐blind, placebo‐controlled single‐ascending‐dose part (0.1–162.5 mg) and a two‐way crossover food‐effect assessment at 62.5 mg in healthy men. Study B was a double‐blind, placebo‐controlled, single‐ and multiple‐ascending‐dose study in overweight or obese (otherwise healthy) men receiving a single dose followed by 14 days of once‐daily dosing (2.5–22.5 mg/day). Safety assessments included clinical evaluations, ECGs and mood and sleep scales. RGH‐706 concentrations in plasma and urine samples were measured by validated methods. Pharmacokinetics was characterized using non‐compartmental analysis. Study B evaluated exploratory pharmacodynamic measures including appetite‐related outcomes, food preference, test‐meal food and macronutrient intake, body composition and metabolic biomarkers. Results In Study A ( n = 68), systemic exposure increased approximately dose proportionally up to 62.5 mg and more than proportionally above, with t max between 2.5 and 3.5 h and a bi‐exponential disposition with a 29–35 h terminal half‐life. Food ingestion had a negligible effect on exposure and renal clearance was also negligible. In Study B ( n = 36), RGH‐706 showed moderate accumulation with steady state reached within 8 days. Exploratory pharmacodynamic measures showed a trend towards lower total energy intake, preference for fatty foods and weight gain, primarily with the lower doses of 2.5 and 7.5 mg/day. RGH‐706 was well tolerated across all doses and conditions in both studies. Conclusions RGH‐706 was safe, well tolerated and exhibited well‐characterized pharmacokinetics. The pharmacodynamic data support further exploration of RGH‐706 in weight management.