Tesomet (tesofensine/metoprolol) / Saniona - LARVOL DELTA

The management of hypothalamic obesity in craniopharyngioma. (PubMed, Best Pract Res Clin Endocrinol Metab) - "The use of dextroamphetamine in some HO patients has proved effective. Emerging therapies include melanocortin-4 receptor (MC4R) agonists such as setmelanotide, which restore anorexigenic signalling, glucagon-like peptide-1 (GLP-1) receptor agonists that enhance satiety and energy expenditure, and combination strategies integrating adrenergic modulation (Tesomet). Despite promising preliminary data, long-term efficacy and safety profiles require further validation. Optimizing precision medicine approaches incorporating polypharmacotherapy and neuroendocrine modulation may redefine therapeutic paradigms for HO management."

Journal • Review • Brain Cancer • CNS Disorders • CNS Tumor • Genetic Disorders • Hypothalamic Injury-associated Obesity • Metabolic Disorders • Obesity • Sleep Disorder • LEP

Social Listening: A Content Analysis of Social Media Discussions in Prader Willi Syndrome (PWS) (ISPOR 2025) - "Posts for treatment advancements (3.1%) featured therapies for hypogonadism, hyperphagia, hypothalamic obesity, and disruptive behaviors, mentioning key treatments like DCCR, Tesomet, Vagus Nerve Stimulation, and bright light therapy... Given the rarity of PWS and the limited clinical or patient information available, analyzing social media discussions highlighted key areas of interest, underrepresented topics, and opportunities for targeted outreach or further research."

Behavior Disorders • Endocrine Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity • Prader–Willi syndrome • Rare Diseases

PWS: Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P2b | N=0 | Withdrawn | Sponsor: Saniona | N=120 ➔ 0 | Trial completion date: Dec 2023 ➔ Dec 2022 | Suspended ➔ Withdrawn

Enrollment change • Trial completion date • Trial withdrawal • Prader–Willi syndrome

Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO) (clinicaltrials.gov) - P2b | N=0 | Withdrawn | Sponsor: Saniona | N=104 ➔ 0 | Trial completion date: May 2024 ➔ Dec 2022 | Suspended ➔ Withdrawn | Trial primary completion date: Aug 2023 ➔ Dec 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity

Safety and Efficacy of Tesomet over 48 Weeks of Treatment; Results From a 24-Week Phase 2, Randomized, Double-Blind Study With 24 Week Open-Label Extension in Adults With Hypothalamic Obesity (ENDO 2022) - "Tesomet resulted in a mean change in body weight (kg) from baseline of -6.34 for the Tesomet-Tesomet group and -6.03 for the placebo-Tesomet group, mean change in waist circumference (cm) from baseline was -5.73 for the Tesomet-Tesomet group and -3.04 for the placebo-Tesomet group. We conclude that tesomet was generally well tolerated after 48 weeks treatment and resulted in clinically meaningful reductions in body weight"

Clinical • P2 data • Cardiovascular • CNS Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity • Pain • Sleep Disorder • Xerostomia

Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO) (clinicaltrials.gov) - P2b | N=104 | Suspended | Sponsor: Saniona | Recruiting ➔ Suspended

Trial suspension • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity

PWS: Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P2b | N=120 | Suspended | Sponsor: Saniona | Recruiting ➔ Suspended

Trial suspension • Prader–Willi syndrome

"BioStock: Saniona on the paused Tesomet programmes and restructuring https://t.co/ISl64scMWy" (@CisionNews)

Randomized Controlled Trial of Tesomet for Weight Loss in Hypothalamic Obesity. (PubMed, Eur J Endocrinol) - "Tesomet was well-tolerated, did not affect heart rate or blood pressure, and resulted in significant reductions in body weight compared to placebo in adults with hypothalamic obesity."

Journal • Cardiovascular • CNS Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity • Pain • Psychiatry • Sleep Disorder • Xerostomia

PWS: Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P2b; N=120; Recruiting; Sponsor: Saniona

Clinical • New P2b trial • Prader–Willi syndrome

A 16-week phase 2b, double-blind, placebo-controlled, Multi center, dose finding safety and efficacy study to evaluate overall safety and tolerability of Tesomet ( tesofensine and metoprolol) in subjects with Prader-Willi Syndrome, and with an optional 38-week open-label extension (clinicaltrialsregister.eu) - P2; N=120; Sponsor: Saniona A/S

Clinical • New P2 trial • Prader–Willi syndrome

A 36-week phase 2b, double-blind, placebo-controlled, Multi center, safety and efficacy study to evaluate overall safety and tolerability of Tesomet ( tesofensine and metoprolol) in subjects with Hypothalamic Obesity, and with an optional 38-week open-label extension (clinicaltrialsregister.eu) - P2; N=104; Sponsor: Saniona A/S

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

Phase 2b Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO) (clinicaltrials.gov) - P2b; N=104; Recruiting; Sponsor: Saniona

Clinical • New P2b trial • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity

[VIRTUAL] Weight Loss, Improved Body Composition and Fat Distribution by Tesomet in Acquired Hypothalamic Obesity (ENDO 2021) - P2 | "Objective This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Cardiovascular • CNS Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity • Psychiatry • Sleep Disorder • Xerostomia

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) (clinicaltrials.gov) - P2; N=21; Completed; Sponsor: Saniona; Active, not recruiting ➔ Completed

Clinical • Trial completion • Genetic Disorders • Obesity

[VIRTUAL] TESOMET CAUSES SIGNIFICANT WEIGHT LOSS RESULTING IN REDUCED LEVOTHYROXINE REQUIREMENTS IN HYPOPITUITARY PATIENTS WITH ACQUIRED HYPOTHALAMIC OBESITY (ENEA 2020) - "This trial investigated safety and efficacy of tesomet (0.5 mg tesofensine and 50 mg metoprolol) in hypopituitary patients with hypothalamic obesity. Twenty-one (16 females) hypopituitary patients with hypothalamic obesity were randomized to tesomet or placebo (2: 1 ) for 24 weeks (nCT03845075). Tesomet was generally well tolerated, did not affect heart rate or blood pressure, resulted in transient appetite-suppression, significant reductions in body weight and waist circumferences compared to placebo in this cohort of hypopituitary patients with hypothalamic obesity. Weight-loss necessitated reductions in levothyroxine dose in most subjects."

Clinical • Cardiovascular • CNS Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Metabolic Disorders • Mood Disorders • Obesity • Pain • Psychiatry • Sleep Disorder • Xerostomia

Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2; N=60; Completed; Sponsor: Saniona; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) (clinicaltrials.gov) - P2; N=21; Active, not recruiting; Sponsor: Saniona; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

TM002: Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) (clinicaltrials.gov) - P2; N=18; Completed; Sponsor: Saniona; Recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ Jun 2019

Clinical • Trial completion • Trial completion date

A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate (clinicaltrials.gov) - P1; N=37; Completed; Sponsor: Saniona; Recruiting ➔ Completed; N=60 ➔ 37

Enrollment change • Trial completion