bivamelagon (LB54640) / LG Chem, Rhythm Pharma - LARVOL DELTA

Rhythm Pharmaceuticals Announces Three Late-breaking Data Abstracts Accepted for Presentation at ENDO 2025 (GlobeNewswire) - "Rhythm Pharmaceuticals...today announced that three late-breaking abstracts have been accepted for presentation at The Endocrine Society’s Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA...In a live oral presentation, Susan Phillips, M.D., Pediatric Endocrinology, University of California San Diego/Rady Children’s Hospital, San Diego, will present data from Rhythm’s pivotal Phase 3 TRANSCEND trial evaluating setmelanotide in the largest randomized, placebo-controlled trial in acquired hypothalamic obesity to date....Vidhu Thaker, M.D., Pediatric Endocrinology, Columbia University, New York City will present a poster from the 14-week, multicenter, international, randomized, double-blind, placebo-controlled Phase 2 trial of bivamelagon, an oral MC4R agonist (formerly LB54640), in participants with acquired hypothalamic obesity."

Clinical data • Obesity

Rhythm Pharmaceuticals Reports First Quarter 2025 Financial Results and Business Update (GlobeNewswire) - "Submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide for the treatment of patients with acquired HO in the third quarter of 2025; Announce topline data from the bivamelagon Phase 2 trial in acquired HO in the third quarter of 2025; Complete enrollment in the setmelanotide Phase 2 trial in PWS in the second half of 2025; Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired HO in the second half of 2025."

EMA filing • FDA filing • P2 data • Trial status • Obesity • Prader–Willi syndrome

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Rhythm Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity

Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Business (GlobeNewswire) - "Begin enrolling the first patients with congenital HO in a 34-week substudy of setmelanotide being conducted under the protocol for its global Phase 3 trial in the first quarter of 2025; Begin enrolling the first patients with Prader-Willi syndrome (PWS) in a 26-week, open-label Phase 2 trial evaluating setmelanotide in the first quarter of 2025; Begin enrolling patients with acquired HO in Part C of the Phase 1 trial evaluating the weekly, MC4R agonist RM-718 in the first quarter of 2025; Announce top-line data in the Phase 3 trial evaluating setmelanotide in acquired HO in the second quarter of 2025; Announce topline data from the Phase 2 trial of bivamelagon in acquired HO in the second half of 2025; and Announce top-line data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first half of 2026."

Enrollment status • P2 data • P3 data: top line • Hypothalamic Injury-associated Obesity • Metabolic Disorders • Obesity • Prader–Willi syndrome

Rhythm Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Business (GlobeNewswire) - "Today, the Company announced that it raised approximately $75 million in gross proceeds from the sale of approximately 1.3 million shares of common stock...Today, Rhythm announced that it completed enrollment in the Phase 2 trial evaluating oral MC4R agonist bivamelagon (LB54640) in acquired hypothalamic obesity...Net product revenues relating to global sales of IMCIVREE were $41.8 million for the fourth quarter of 2024 and $130.1 million for the full year of 2024..."

Commercial • Enrollment closed • Financing • Metabolic Disorders • Obesity

Rhythm Pharmaceuticals Announces Preliminary Fourth Quarter and Full Year 2024 Net Product Revenues, Pipeline Advancements and Upcoming Milestones (GlobeNewswire) - "Rhythm is on track to complete enrollment in the Phase 2 trial evaluating bivamelagon, an oral MC4R agonist, in acquired HO in the first quarter of 2025...Following acceptance of a protocol amendment, Rhythm expects to begin dosing patients with acquired HO in Part C of the Phase 1 trial evaluating RM-718, a weekly MC4R agonist, in the first quarter of 2025."

Enrollment status • Trial status • Metabolic Disorders • Obesity

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Rhythm Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Rhythm Pharmaceuticals, Inc. | Initiation date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Mar 2025 ➔ Jan 2026

Trial initiation date • Trial primary completion date • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity

A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Genetic Obesity (clinicaltrials.gov) - P2 | N=4 | Not yet recruiting | Sponsor: LG Chem

New P2 trial • Genetic Disorders • Leptin Receptor Deficiency Obesity • Obesity • POMC-null Obesity • PCSK1

A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects (clinicaltrials.gov) - P1 | N=112 | Completed | Sponsor: LG Chem

New P1 trial • Obesity

A Phase 2, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: LG Chem

New P2 trial • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity