Evidence map›Paper›PMID 35294397›Full record

Trial reportEuropean journal of endocrinology2022

Randomized controlled trial of Tesomet for weight loss in hypothalamic obesity.

Kim Huynh, Marianne Klose, Kim Krogsgaard, Jørgen Drejer, Sarah Byberg, Sten Madsbad, Faidon Magkos, Abdellatif Aharaz, Berit Edsberg, Jacob Tfelt-Hansen and 2 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of endocrinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Approach to the patient with acquired hypothalamic syndrome.The Journal of clinical endocrinology and metabolism · 2026
    Review
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  7. Multidisciplinary Therapy to Target Obesity and Its Complications in Adult Population: A Narrative Review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
    Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Treatment of Hypothalamic Obesity With GLP-1 Analogs.Journal of the Endocrine Society · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Kim HuynhDepartment of Medical Endocrinology and Metabolism PE 2131/2, Copenhagen University Hospital (Rigshospitalet), Copenhagen Ø, Denmark.
Marianne KloseDepartment of Medical Endocrinology and Metabolism PE 2131/2, Copenhagen University Hospital (Rigshospitalet), Copenhagen Ø, Denmark.ORCID 0000-0001-6075-0821
Kim KrogsgaardSaniona A/S, Glostrup, Denmark.
Jørgen DrejerSaniona A/S, Glostrup, Denmark.
Sarah BybergDepartment of Biomedical Sciences, University of Copenhagen, Copenhagen N, Denmark.
Sten MadsbadDepartment of Endocrinology, Hvidovre University Hospital, University of Copenhagen, Hvidovre, Denmark.
Faidon MagkosDepartment of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Frederiksberg C, Denmark.ORCID 0000-0002-1312-7364
Abdellatif AharazDepartment of Endocrinology, Slagelse Hospital, Slagelse, Denmark.
Berit EdsbergSaniona A/S, Glostrup, Denmark.
Jacob Tfelt-HansenDepartment of Cardiology, The Heart Centre, Copenhagen University Hospital (Rigshospitalet), Copenhagen Ø, Denmark.
Arne Vernon AstrupDepartment of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Frederiksberg C, Denmark.
Ulla Feldt-RasmussenDepartment of Medical Endocrinology and Metabolism PE 2131/2, Copenhagen University Hospital (Rigshospitalet), Copenhagen Ø, Denmark.ORCID 0000-0002-5903-3355
University of Copenhagen · DKCopenhagen University Hospital · DKSaniona (Denmark) · DKSlagelse Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Appetite DepressantsHypothalamic DiseasesAdultBody WeightDouble-Blind MethodFemaleHumansMaleObesityQuality of LifeWeight LossAppetite Depressants

Identifiers

PMID35294397
PMCPMC9175551
OpenAlexW4220795619

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.