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Cited by 43Pharmacology and Obesity TreatmentRegulation of Appetite and ObesityEating Disorders and Behaviors

Randomized controlled trial of Tesomet for weight loss in hypothalamic obesity

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Huynh, Kim, Klose, Marianne, Krogsgaard, Kim, Drejer, Jørgen, Byberg, Sarah, Madsbad, Sten, Magkos, Faidon, Aharaz, Abdellatif +4 more·2022·European Journal of Endocrinology
DOI 10.1530/eje-21-0972PMC PMC9175551
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Abstract

Context: Hypothalamic injury often leads to rapid, intractable weight gain causing hypothalamic obesity, which is associated with increased risk of cardiovascular and metabolic morbidity and mortality. There are no approved or effective pharmacological treatments for hypothalamic obesity, and conventional lifestyle management remains ineffective. Objective: To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity. Methods: Twenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks. Patients also received diet/lifestyle counselling. The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile. Results: Eighteen patients completed 24 weeks. Consent withdrawal, eligibility, and serious adverse events (SAE) unrelated to treatment resulted in dropouts. One patient experienced a Tesomet-related SAE of exacerbated pre-existing anxiety leading to treatment discontinuation. Tesomet-related adverse events were otherwise mostly mild and included sleep disturbances (Tesomet 50%, placebo 13%), dry mouth (Tesomet 43%, placebo 0%), and headache (Tesomet 36%, placebo 0%). No significant differences in heart rate or blood pressure were observed between groups. Compared to placebo, Tesomet resulted in additional mean (95% CI) weight change of −6.3% ((−11.3; −1.3); P = 0.017), increased the number of patients achieving ≥5% weight loss (Tesomet 8/13, placebo 1/8; P = 0.046), and tended to augment the reduction in waist circumference by 5.7 cm ((−0.1; 11.5); P = 0.054). Conclusion: Tesomet was welltolerated, did not affect heart rate or blood pressure, and resulted in significant reductions in body weight compared to placebo in adults with hypothalamic obesity.

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  • A small trial using tesofensine plus metoprolol resulted in weight loss in hypothalamic obesity.

    “Finally, a small trial using tesofensine plus metoprolol (the latter to avoid potential adverse cardiovascular effects of tesofensine) resulted in weight loss in hypothalamic obesity (52), but at the time of this writing, tesofensine is not approved for clinical use.”

    From Approach to the patient with acquired hypothalamic syndrome (2026) · cites this paper as [52]

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References 52 · Cited by 43

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Authors
Huynh, K., Klose, M., Krogsgaard, K., Drejer, J., Byberg, S., Madsbad, S., Magkos, F., Aharaz, A., Edsberg, B., Tfelt-Hansen, J., Astrup, A. V., & Feldt-Rasmussen, U.
Affiliations
  • Copenhagen University Hospital (DK)
  • Saniona (Denmark) (DK)
  • University of Copenhagen (DK)
  • Slagelse Hospital (DK)
  • Department of Cardiology, The Heart Centre, Copenhagen University Hospital (Rigshospitalet), Copenhagen Ø, Denmark
Corresponding author
Feldt-Rasmussen, Ulla
ORCID
Venue
European Journal of Endocrinology
Publisher
Oxford University Press (OUP)
Published
2022-06-01
Volume
186
Issue
6
Pages
687-700
ISSN
  • 0804-4643 (ISSN-L)
  • 1479-683X
DOI
10.1530/eje-21-0972
PMC
PMC9175551
OpenAlex
W4220795619
Cited by
43
References
52
Citations by year
2026: 11 · 2025: 11 · 2024: 10 · 2023: 10 · 2022: 1
FWCI
4.79
Type
journal article
Language
en
Open access
Licence
Locations
  • European Journal of Endocrinology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
Funders
European Neuroendocrine Association
Topics
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
  • Social Sciences › Psychology › Clinical Psychology › Eating Disorders and Behaviors
Keywords
hypothalamic obesity, metoprolol, weight loss, appetite, drug safety, adverse events, waist circumference, cardiovascular risk, metabolic profile, quality of life
MeSH terms
Adult, Appetite Depressants, Body Weight, Double-Blind Method, Female, Humans, Hypothalamic Diseases, Male, Obesity, Quality of Life, Weight Loss

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