Hypothalamic Obesity

Metabolic Diseases
8
Pipeline Programs
2
Companies
7
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
1
3
0
2
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
4100%
+ 3 programs with unclassified modality

On Market (1)

Approved therapies currently available

Rhythm Pharmaceuticals
IMCIVREEApproved
setmelanotide
Rhythm Pharmaceuticals
Melanocortin 4 Receptor Agonist [EPC]subcutaneous2020

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Rhythm Pharmaceuticals
6 programs
1
3
2
1
SetmelanotidePhase 3Peptide1 trial
SetmelanotidePhase 3Peptide1 trial
BivamelagonPhase 21 trial
LB54640Phase 21 trial
SetmelanotidePhase 2Peptide1 trial
+1 more programs
Active Trials
NCT06239116Recruiting150Est. Nov 2028
NCT07156578Enrolling By Invitation25Est. Apr 2028
NCT06046443Completed28Est. Feb 2026
+3 more trials
Novartis
NovartisBASEL, Switzerland
1 program
1
OctreotidePhase 4Peptide1 trial
Active Trials
NCT00171613Completed32

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
NovartisOctreotide
Rhythm PharmaceuticalsSetmelanotide
Rhythm PharmaceuticalsSetmelanotide
Rhythm PharmaceuticalsBivamelagon
Rhythm PharmaceuticalsLB54640
Rhythm PharmaceuticalsSetmelanotide
Rhythm PharmaceuticalsPart A: RM-718 or placebo

Clinical Trials (7)

Total enrollment: 412 patients across 7 trials

NCT00171613NovartisOctreotide

A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients

Start: Feb 200532 patients
Phase 4Completed
NCT06760546Rhythm PharmaceuticalsSetmelanotide

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Start: Sep 2025Est. completion: Mar 202839 patients
Phase 3Recruiting
NCT05774756Rhythm PharmaceuticalsSetmelanotide

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Start: Apr 2023Est. completion: Apr 2027120 patients
Phase 3Active Not Recruiting
NCT07156578Rhythm PharmaceuticalsBivamelagon

A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

Start: Nov 2025Est. completion: Apr 202825 patients
Phase 2Enrolling By Invitation
NCT06046443Rhythm PharmaceuticalsLB54640

A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity

Start: Jul 2024Est. completion: Feb 202628 patients
Phase 2Completed
NCT04725240Rhythm PharmaceuticalsSetmelanotide

Open-Label Study of Setmelanotide in Hypothalamic Obesity

Start: Jun 2021Est. completion: Jun 202218 patients
Phase 2Completed
NCT06239116Rhythm PharmaceuticalsPart A: RM-718 or placebo

A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment

Start: Mar 2024Est. completion: Nov 2028150 patients
Phase 1/2Recruiting

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 412 patients
Peptide is the dominant modality (100% of programs)
2 companies competing in this space

Related Indications

Diabetes(737)Diabetes Mellitus, Type 2(485)Obesity(246)Type 2 Diabetes(207)Type 2 Diabetes Mellitus(190)Diabetes Mellitus(127)Diabetes Mellitus, Type 1(95)Type 1 Diabetes Mellitus(51)Type 1 Diabetes(50)Dyslipidemia(45)