Oratrope (ibutamoren) / Merck (MSD), Lumos Pharma - LARVOL DELTA

Baseline Growth and Metabolic Predictors of Growth Hormone Responsiveness to LUM‑201 Versus Standard Stimulation in Children with Moderate GHD (ESPE 2026) - No abstract available

Clinical

Baseline Growth and Metabolic Predictors of Growth Hormone Responsiveness to LUM‑201 Versus Standard Stimulation in Children with Moderate GHD (ESPE 2026) - No abstract available

Clinical

Not Safer Than Steroids: Biopsy-Proven Designer Androgen Cholestasis Following Multi-Agent âSARMâ Supplement Use (ACG 2026) - "Case Description/ A 31-year-old man without prior liver disease presented with one month of progressive pruritus, jaundice, and acholic stools following use of a bodybuilding supplement âIron Solderâ containing four SARMs (LGD-4033, MK-2866, RAD-150, YK-11), a growth hormone secretagogue (MK-677/ibutamoren), and an aromatase inhibitor (arimistane)...The supplement was discontinued and the patient received cholestyramine and ursodiol symptomatically...Databases such as LiverTox provide freely accessible hepatotoxicity profiles for SARMs and may aid evaluation. Figure: Figure 1: H&E, low power - Liver biopsy core demonstrating preserved lobular architecture with bland cholestasis and minimal inflammation Figure: Figure 2: H&E, high power â canalicular bile plugging with intrahepatic cholestasis and focal hepatocyte dropout"

Biopsy • Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Failure • Pruritus

Severe Cholestatic Drug-Induced Liver Injury Associated With SARM Stacking and Herbal Supplements (ACG 2026) - "He reported three years of Ashwagandha, Fadogia root, and Tongkat Ali herbal use, with recent stacking of RAD-140, LGD-4033, and MK-677...N-acetylcysteine and ursodiol were initiated...He was discharged on an oral prednisone taper...Lastly, transaminase fluctuations during recovery should be interpreted with adjunctive markers such as creatine phosphokinase, aldolase, and 5'-nucleotidase to avoid unnecessary steroid use. Figure: Figure 1: Visualization of the liver enzyme and total bilirubin trend during the treatment and recovery course with significant events noted."

Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Failure • Myositis • Pruritus

Peptide Supplements and Their Therapeutic Applications in Sports Medicine. (PubMed, Am J Sports Med) - "Despite promising findings in animal studies, the claimed benefits of emerging peptide supplements for musculoskeletal recovery and performance remain unsubstantiated by current human trials. Documented risks include cardiovascular complications and metabolic dysfunction such as insulin resistance. Because of the lack of robust efficacy and safety data, peptide supplements should not currently be recommended as a replacement or adjunct for existing orthopaedic standard of care."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • TMSB4X

Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults (clinicaltrials.gov) - P2 | N=202 | Not yet recruiting | Sponsor: Lumos Pharma

New P2 trial • Genetic Disorders • Obesity

Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Lumos Pharma | Initiation date: Sep 2026 ➔ Feb 2027

Trial initiation date • Endocrine Disorders • Growth Hormone Deficiency

Striosomal ghrelin receptor activity controls reward-cost integration. (PubMed, Res Sq) - "We observed dose-dependent effects of the GHSR agonist ibutamoren (IBU) on rat decision-making performance...Chemogenetic manipulation of dorsomedial striosomes activity confirmed their causal influence on both GHSR-mediated increases in cost-sensitivity and circuit activity in LHb and daSNc. Our results identify a novel circuit mechanism linking endocrine activity with conflict decision-making."

Journal

Rapid and harmonized analytical workflow for the determination of peptidic and non-peptidic doping agents in dried and liquid blood matrices. (PubMed, Analyst) - "The method was successfully applied to samples containing sub-ng levels of ibutamoren, confirming that the analytical procedure presented in this study is fit for purpose within the doping-control framework. At 4 and 22 °C, alexamorelin, AOD9604, buserelin, hGH 176-191, kisspeptin-10 and LHRH were extensively degraded after one week in serum and plasma, whereas BPC-157, TB500, vasopressin, lypressin, and terlipressin showed complete degradation only in serum. In contrast, in dried matrices all compounds remained detectable throughout the entire duration of the study, indicating that samples can be transported and stored under non-refrigerated conditions, thereby reducing costs."

Journal

The Growth Hormone Secretagogue LUM-201 Induces Insulin Sensitivity Index-Dependent Reorganisation of GH Chronobiology, Driven by Higher-Order, Multi-Timepoint Interactions (ENDO 2026) - "Functional principal component analysis (fPCA) on GH-secretion trajectories yielded eigenfunctions capturing amplitude-phase structure. 2. Matsuda, M. & DeFronzo, R. A. Diabetes Care 22, 1462–1470 (1999)."

Diabetes • Metabolic Disorders

Combination LUM-201 and Semaglutide Enhances Weight Loss and Preserves Lean Mass in Diet-Induced Obesity: Translational Rationale for a Phase 2 Study in Adults with Obesity (ADA 2026) - "LUM-201 and semaglutide combination enhances weight loss, preserves lean mass, and improves metabolic function in DIO mice. These effects will be evaluated in a Phase 2 trial in obesity focusing on weight loss, muscle preservation, motor function and quality of life."

Clinical • P2 data • Metabolic Disorders • Obesity

Combination LUM-201 and Semaglutide Enhances Weight Loss and Preserves Lean Mass in Diet-Induced Obesity: Translational Rationale for a Phase 2 Study in Adults with Obesity (ADA 2026) - "LUM-201 and semaglutide combination enhances weight loss, preserves lean mass, and improves metabolic function in DIO mice. These effects will be evaluated in a Phase 2 trial in obesity focusing on weight loss, muscle preservation, motor function and quality of life."

Clinical • P2 data • Metabolic Disorders • Obesity

Spontaneous Splenic Rupture in a Patient With Recent Use of Performance-Enhancing Compounds: A Case Report and Literature Review. (PubMed, Cureus) - "We explore the potential and speculative role of performance-enhancing compounds in precipitating splenic complications, drawing parallels to the established association between traditional anabolic steroids and peliosis - blood-filled vascular cavities that predispose to rupture. While RAD-140 and MK-677 have not been previously linked to splenic pathology, their pharmacological effects on androgen receptor signalling and IGF-1 pathways warrant consideration as possible contributing factors, particularly in the context of a suspected pre-existing vascular malformation. Early recognition, aggressive resuscitation, and timely surgical intervention remain critical, as delayed diagnosis carries significant mortality."

Journal • Hematological Disorders • Pain • IGF1

Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Lumos Pharma | Initiation date: Jan 2026 ➔ Apr 2026

Trial initiation date • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Acute stress suppresses hunger-driven food seeking through PVN activation: Reversal by anxiolytic drug and ghrelin receptor agonist, with anxiolytic-like effects of refeeding. (PubMed, Neurosci Res) - "Acute restraint abolished fasting-induced increases in food seeking and intake, an effect that was reversed by intraperitoneal diazepam, an anxiolytic, and by MK-677, a ghrelin receptor agonist that enhances appetite. Notably, refeeding after fasting induced a similar pPDH-dominant pattern and attenuated stress-induced anxiety-related behaviors, indicating that restoration of energy balance exerts intrinsic anti-stress effects through PVN inhibition. Together, these findings reveal that acute stress suppresses hunger-driven food seeking via PVN activation, pharmacological inhibition reverses this suppression, and physiological refeeding promotes stress resilience via PVN-medicated inhibition, highlighting PVN modulation as a shared mechanism linking emotional and metabolic homeostasis."

Journal • Mood Disorders • Psychiatry • FOS

LUM-201 Augments Weight & Fat Tissue Loss While Preserving Lean Mass in GLP-1 Treatment of DIO Mice (OBESITY WEEK 2025) - "LUM-201 used in combination with semaglutide augments the efficacy of single-agent semaglutide for treatment of diet-induced obesity in mice. The combination of LUM-201 dosed + semaglutide improves weight loss compared with semaglutide solo. Importantly, the combination also preserves lean muscle mass in the context of weight loss compared with single-agent semaglutide.More broadly considered, these findings suggest that combining LUM-201 with GLP-1 receptor agonists could augment the health benefits of GLP-1 receptor agonists by enhancing weight loss while concurrently preserving lean muscle mass."

Preclinical • Genetic Disorders • Obesity

Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213) (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Lumos Pharma | Active, not recruiting ➔ Completed

Trial completion • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Lumos Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Growth Hormone Deficiency

Knowing the minimal detectable dose can facilitate the interpretation of a hair test result: II. Case example with ibutamoren (MK-677), a growth hormone secretagogue. (PubMed, Clin Chim Acta) - "The interpretation of the findings of ibutamoren in human hair can be established in the light of these new data as the minimal detectable dose has been established, as well as the range of concentrations after a regimen of 60 days for performance enhancement."

Journal

Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Lumos Pharma

New P3 trial • Endocrine Disorders • Growth Hormone Deficiency

The Impact of the Oral Growth Hormone Secretagogue Ibutamoren on Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Adults With Overweight/Obesity (ENDO 2025) - P2 | "In this pilot study, we demonstrated a possible beneficial signal of ibutamoren on IHL in an as-treated secondary analysis but were unable to demonstrate this effect in our primary analysis or an effect on body composition in either analysis. Future larger studies could investigate oral ibutamoren co-administered with weight loss medications such as GLP-1 receptor agonists, a combination which may offset the negative glycemic effect of ibutamoren while harnessing the potential for GH augmentation to further reduce liver fat and preserve muscle mass."

Clinical • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • IGF1

Phase 3 Randomized and Double-blinded Trial Design with LUM-201 vs Placebo to Evaluate the Efficacy and Safety of this Daily Oral Growth Hormone Secretagogue in Treatment-Naïve Children with Growth Hormone Deficiency (GHD) (ENDO 2025) - "By stimulating endogenous GH release via the GH-releasing hormone pathway and reducing somatostatin activity, LUM-201 preserves the physiological feedback loop, distinguishing it from exogenous GH injections. The OraGrowtH Phase 3 trial aims to further evaluate LUM-201's efficacy and safety as an oral treatment for GHD."

Clinical • P3 data • Endocrine Disorders • Growth Hormone Deficiency • Pediatrics • IGF1

Ibutamoren Mesylate, an Oral Growth Hormone (GH) Secretagogue, Modifies Body Composition in Healthy Older Adults by Increasing Both the Amount and the Pattern of Endogenous GH Secretion (ENDO 2025) - "This analysis indicates both the amount and the variation in GH secretion in healthy older adults treated with IB influences changes in body composition, in both for the 12hr day-time GH secretion and for the full 24hr profile. These effects of Ibutamoren on physiological GH secretion reinforce the importance of pulse profiles to GH action."

Clinical • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Sarcopenia

Higher Order Time Series Interactions Within The Growth Hormone (GH) Secretion Profile Mark Growth Responsiveness Induced By The Oral Growth Hormone Secretagogue Lum-201 (ENDO 2025) - "ESPE (2024), FC15.2 3. Carletti et al 2020.Physical review E, p.022308"

Late-breaking abstract • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

Oral Growth Hormone Secretagogue (LUM-201) Pediatric Capsule Formulation Demonstrates Similar Pharmacokinetic (PK) Bioavailability and Pharmacodynamic (PD) Responses to Current Tablet Formulation (ENDO 2025) - "No significant differences in PK or PD were observed in comparisons of fasted versus fed state. Thus, regardless of formulation or administration method, the immediate GH release stimulated by LUM-201 results in similar GH Cmax values."

Clinical • PK/PD data • Pediatrics • IGF1