Drugs / LB54640

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06040372 Mar 2020 → Mar 2022 obesity disorder LG Chem Completed No outcome recorded
Phase 22 trials
Phase 2 NCT06046443 Jul 2024 → Feb 2026 acquired hypothalamic obesity Rhythm Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT06041841 Dec 2023 → Dec 2024 obesity due to leptin receptor gene deficiency, obesity due to pro-opiomelanocortin deficiency, obesity due to prohormone convertase I deficiency LG Chem Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-07-09 Rhythm Pharmaceuticals, Inc. Results Rhythm Pharmaceuticals Announces Oral MC4R Agonist Bivamelagon Achieved Statistically Significant, Clinically Meaningful BMI Reductions in Placebo-controlled Phase 2 Trial in Acquired Hypothalamic Obesity rhythmtx.com ↗
Bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment, consistent with BMI reductions achieved with setmelanotide therapy in similar patient populations in past trials.
2022-06-16 LG Life Sciences Regulatory LG Chem’s New Drug for Obesity Receives Additional Orphan Drug Designation by the US FDA lgchem.com ↗
LG Chem announced on 16th that the FDA recently gave ODD for ‘LB54640’ to treat ‘POMC (Proopiomelanocortin) deficiency.’
2020-09-28 LG Life Sciences Regulatory LG Chem Accelerates Development of New Obesity Treatment Drug lgchem.com ↗
Regarding this, LG Chem announced that it received orphan drug designation as a genetic obesity treatment from the US Food & Drug Administration (FDA) for the new drug project ‘LG54640’ that is currently in clinical stage 1 in the US.

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as LB54640 “The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.” NCT06040372 ↗
2

NCT06046443 ↗

NCT06041841 ↗

Route Oral “LB54640 QD Oral” NCT06041841 ↗