Egrifta SV (tesamorelin acetate) / Future Pak, Massachusetts General Hospital - LARVOL DELTA

Efficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis. (PubMed, J Int Assoc Provid AIDS Care) - "However, limited data on long-term safety, optimal dosing strategies, and durability of treatment effects warrant caution. Future research should evaluate extended treatment duration, dose-response relationships, and patient-reported outcomes to establish comprehensive clinical utility."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • Obesity

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol. (PubMed, BMJ Open) - P2 | "Study findings will be disseminated through peer-reviewed publications and scientific conferences and may inform future interventions to improve physical function among older adults living with HIV. NCT06554717."

Clinical protocol • Journal • Human Immunodeficiency Virus • Infectious Disease • Obesity

The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. (PubMed, Front Endocrinol (Lausanne)) - "The agents most commonly encountered in clinical practice and online self-administration protocols include growth hormone-releasing hormone (GHRH) analogues (e.g., sermorelin, tesamorelin, CJC-1295 with Drug Affinity Complex [DAC], CJC-1295 without DAC), growth hormone secretagogues (GHS; e.g., growth hormone-releasing peptide-2 (GHRP-2), growth hormone-releasing peptide-6 (GHRP-6), hexarelin, ipamorelin), the growth hormone (GH) fragment - AOD9604 (hGH 176-191), and insulin-like growth factor-1 (IGF-1) analogues (e.g., pegylated mechano growth factor (PEG-MGF), IGF-1 Long R3 (IGF-1 LR3)). We summarise structural characteristics, pharmacologic effects, and commonly reported dosing patterns, and we synthesise clinically relevant adverse effects with particular attention to hormonal imbalance, endocrine-metabolic risk, and biologically plausible but unproven mitogenic concerns. Finally, we propose a clinically oriented assessment algorithm to support exposure history..."

Journal • Review • Endocrine Disorders • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • IGF1

The effect of growth hormone-releasing hormone on cognition and brain connectivity in adults with cognition ranging from normal to mild cognitive impairment. (PubMed, eNeurologicalSci) - P1 | "In a double-blind, placebo-controlled pilot trial, we assessed 22 subjects with baseline cognition ranging from normal cognition to mild cognitive impairment before and after 10 weeks of treatment with low-dose tesamorelin (1 mg; GHRH analog) or placebo...This pilot study highlights the potential benefits of pairing cognitive tests and neuroimaging with ML tools to achieve greater sensitivity for treatment-related effects. The clinical trial registration number is: NCT02553603."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Fatigue

Injectable Peptides in Sports Medicine: A Structured Narrative Review of Evidence, Safety, and Antidoping Implications. (PubMed, JBJS Rev) - "Injectable peptides for sports medicine remain largely experimental. Clinical use should be confined to approved metabolic agents for indicated conditions and to rigorously designed research protocols. Clinicians caring for athletes must counsel patients regarding uncertain efficacy, product quality, safety risks, and antidoping implications."

Journal • Review • Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives. (PubMed, Int J Mol Sci) - "Our results suggest that therapeutic peptides are a promising tool for treating type 2 diabetes and obesity, for skin rejuvenation, and as hormone analogs for specific diseases and conditions. Although these are strategic and innovative options that can improve health, performance, and longevity, further studies are needed before most new peptides can be used safely in humans."

Journal • Review • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Preventive care • Type 2 Diabetes Mellitus

TRIUMPH: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jun 2028 ➔ Dec 2028 | Trial primary completion date: Jan 2028 ➔ Jun 2028

Trial completion date • Trial primary completion date • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity • CD4

Body Composition and Adipose Tissue in HIV (clinicaltrials.gov) - P4 | N=6 | Terminated | Sponsor: Columbia University | Completed ➔ Terminated; lack of availability of the study drug

Trial termination • Endocrine Disorders • Growth Hormone Deficiency • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • CD4

Differing Presentations of Excess Visceral Abdominal Fat in People Living With HIV: Two Clinical Cases Highlighting Distinct Therapeutic Pathways With Tesamorelin and Glucagon-Like Peptide-1 Receptor Agonists. (PubMed, Clin Infect Dis) - "These cases highlight the heterogeneity of EVAF in PLWH and support individualized management strategies informed by fat distribution rather than weight alone."

Journal • Cardiovascular • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Obesity

Combined antiretroviral therapy with low- or normal-protein, high-calorie diets appears to induce significant deleterious electrocardiographic changes in a rodent model. (PubMed, Braz J Med Biol Res) - "Each dietary group was then subdivided into four treatment groups for a further 9 weeks: a standard group (normal saline), Test group 1 (dolutegravir (DTG) plus tesamorelin), Test group 2 (DTG only), and a positive control (classical cART regimen)...Significant intergroup variations in ECG indices were observed, including Q, R, S, and T wave amplitudes, PR interval, QRS duration, ST height, and QTc (all P<0.0001)...These findings demonstrated that CDLP and CDNP diets, combined with DTG-based or classical cART regimens, exerted deleterious cardiac effects, promoting myocardial fibrosis that disrupts normal electrical conduction and may predispose to arrhythmogenesis. Tesamorelin prevented these effects, implicating growth hormone pathway dysfunction in the underlying pathology."

Journal • Preclinical • Cardiovascular • Fibrosis • Human Immunodeficiency Virus • Immunology • Infectious Disease

Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. (PubMed, Sports Med) - "Our objective is to present the pharmacological mechanisms, safety profiles, and regulatory status of prominent approved and unapproved peptides marketed direct to patients, including AOD-9604 (anti-obesity drug 9604), BPC-157 (body protection compound 157), CJC-1295, FS-344 (follistatin-344), GHK-Cu (glycyl-L-histidyl-L-lysine copper), ipamorelin, MOTS-C (mitochondrial ORF of the 12S rRNA type-c), sermorelin, SS-31 (elamipretide), tesamorelin (Egrifta), Tβ4 (thymosin beta-4), and TB-500 (thymosin beta-4 fragment). We provide a framework to navigate patient discussions about peptides to better facilitate evidence-based practices for musculoskeletal healing and athletic performance. We also discuss the placebo effect as a mediator of peptide efficacy, and how social media amplifies this effect."

Journal • Review • Genetic Disorders • Musculoskeletal Diseases • Obesity • TMSB4X

TESA-LIVER: Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Hudson Biotech

New P2 trial • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Pharmacologic Treatments for the Preservation of Lean Body Mass During Weight Loss. (PubMed, J Clin Med) - "There are several mechanisms that govern the loss of lean body mass and, more specifically, the loss of muscle mass; as such, several classes of medications have been explored, targeting different pathways and receptors-including bimagrumab (activin receptor agonist), tesamorelin (growth hormone releasing hormone agonists), and enobosarm (selective androgen receptor modulator). Most of these drugs are in the early phases of research development, but some show great promise. This narrative review attempts to detail the physiology of muscle mass loss when accompanied by weight loss and identify pharmacological targets that can be utilized to minimize it with mechanisms, effects, side effects, and research developmental progress."

Journal • Review • Genetic Disorders • Obesity

Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials. (PubMed, Obes Res Clin Pract) - "Tesamorelin improves body composition, hepatic fat, lean body mass, and IGF-1 levels in HIV-associated lipodystrophy, without serious side effects or perturbation of glucose."

Journal • Retrospective data • Review • Cardiovascular • Dermatology • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • Musculoskeletal Pain • Pain • CD4 • IGF1

Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions. (PubMed, J Am Acad Orthop Surg Glob Res Rev) - "Wound-healing peptides such as BPC-157, TB-500, and GHK-Cu promote angiogenesis, integrin-mediated extracellular matrix remodeling, and fibroblast activation, whereas growth hormone secretagogues like ipamorelin, CJC-1295, tesamorelin, sermorelin, and AOD-9604 activate IGF-1 signaling and satellite cell repair. Although preclinical studies are promising, there is a current lack of clinical trials. This review integrates current mechanistic insights with orthopaedic relevance, emphasizing safety, efficacy, and future directions for responsible integration into musculoskeletal care."

Journal • Review • Inflammation • Musculoskeletal Diseases • Orthopedics • AMPK • IGF1 • MET • TGFB1

Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians. (PubMed, Am J Sports Med) - "While peptide therapy may possess significant therapeutic and regenerative potential, it is critical that orthopaedic and sports medicine providers understand the current lack of evidence to support the clinical use of these peptides. Importantly, information regarding the indications, dosing, frequency, and duration of treatment remains unknown. Despite the popularity of these peptides in mainstream media and among patients, significant research regarding the safety and efficacy of these therapeutic methods is required before definitive recommendations can be made to patients."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics • Pain

Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (clinicaltrials.gov) - P2 | N=51 | Completed | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Completed | N=76 ➔ 51

Enrollment change • Trial completion • Cardiovascular • Colon Cancer • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Muscular Atrophy

Analysis of growth hormone releasing hormone and its analogs in urine using nano liquid chromatography coupled with quadrupole/orbitrap mass spectrometry. (PubMed, J Pharm Biomed Anal) - "The present study aimed to develop a robust nano-LC quadrupole/orbitrap mass spectrometry (nano-LC-Q/Orbitrap MS) method for both screening and confirmation analyses of GHRH and its synthetic analogs (sermorelin/CJC-1293, tesamorelin, and CJC-1295) and the primary metabolite of sermorelin in urine, in accordance with WADA requirements...The validation results confirmed the method's suitability and robustness for anti-doping testing. Achieved LODs (≤ 0.5 ng/mL) and LOIs (0.5-0.75 ng/mL) demonstrated sufficient sensitivity for effective detection and confirmation analysis of the target peptides in urine."

Journal

TRIUMPH: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Carpal Tunnel Syndrome Attributed to Medication Use: A Pharmacovigilance Study. (PubMed, Cureus) - "Several drugs were disproportionately associated with CTS in the FAERS database, including enzyme replacement therapies (ERTs), aromatase inhibitors, bisphosphonates, growth hormone (GH)-releasing factor analogs, GHB, rofecoxib, and tafamidis. These findings highlight the critical need for increased vigilance and monitoring of new-onset or worsening CTS in high-risk populations prescribed the aforementioned medications. Clinicians should carefully scrutinize pharmacological history when evaluating patients in this context."

Adverse events • Journal • Musculoskeletal Pain • Pain

Metabolic dysfunction-associated steatotic liver disease in people with HIV. (PubMed, Curr Opin HIV AIDS) - "MASLD is a key contributor to liver-related and cardiovascular-morbidity in PWH. While there have been exciting advances to improve diagnosis and management of MASLD in the general population, differences in MASLD pathophysiology demonstrate the need to tailor our approach specifically for PWH."

Journal • Cardiovascular • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Body Composition and Adipose Tissue in HIV (clinicaltrials.gov) - P4 | N=5 | Completed | Sponsor: Columbia University | Recruiting ➔ Completed | N=24 ➔ 5

Enrollment change • Trial completion • Endocrine Disorders • Growth Hormone Deficiency • Human Immunodeficiency Virus • Infectious Disease • Lipodystrophy • Metabolic Disorders • CD4

TRIUMPH: Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Massachusetts General Hospital | Initiation date: Mar 2025 ➔ Jul 2025

Trial initiation date • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease • Obesity

Therapeutic potential of a GHRH analog in experimental MASLD (EASL 2025) - "Tesamorelin administration induced a reduction of adipose tissue with consequent weight loss. Also, it improved liver enzymes, lipid profile and insulin resistance. Further experiments are needed to better understand and isolate peripherical GH effects from IGF-1-mediated liver protection."

Fibrosis • Genetic Disorders • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • IGF1