Study of INV-202 in Patients With Obesity and Metabolic Syndrome

Summary

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.

Timeline

Start

2023-09-08

Primary completion

2024-06-13

Completion

2025-02-14

Outcome

Met primary endpoint

paper At week 16, participants receiving monlunabant showed statistically significant weight loss compared with those receiving placebo PMID 41038215 ↗

paper least squares mean difference vs placebo of -6·4 kg [95% CI -8·0 to -4·9] for monlunabant 10 mg PMID 41038215 ↗

release “From a baseline body weight of 110.1 kg, all doses of monlunabant achieved a statistically significant weight loss compared to placebo.” novonordisk.com ↗

Publications

• Knop FK, Kunos G, Dicker D, Paquette JS, Aronne L, Frenkel O, Holst-Hansen T, Lalonde K, Lee J, Crater G; trial investigators. Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):911-923. doi: 10.1016/S2213-8587(25)00216-5. Epub 2025 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Monlunabant	Small molecule	10 mg	Oral
Subject	Monlunabant	Small molecule	20 mg	Oral
Subject	Monlunabant	Small molecule	50 mg	Oral

Indications