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

Huynh K, Klose M, Krogsgaard K, Drejer J, Byberg S, Madsbad S, Magkos F, Aharaz A, Edsberg B, Tfelt-Hansen J, Astrup AV, Feldt-Rasmussen U

European journal of endocrinology9 May 2022Cited by 38 (Europe PMC)

PMID35294397PMCIDPMC9175551DOI10.1530/eje-21-0972PepBankPUB-35294397

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Summary

ContextHypothalamic 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.ObjectiveTo investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-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.ResultsEighteen 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).ConclusionTesomet 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.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone9

In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Tesofensine.

01HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome
In adults with hypothalamic obesity, sleep disturbances occurred in 50% with Tesomet versus 13% with placebo.
In plain wordsIn adults with hypothalamic obesity, sleep disturbances occurred in 50% with Tesomet and 13% with placebo.
Peptide
Tesofensine
Outcome
IncreaseSleep disturbances
Study
n = 21
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Sleep
Measurements
Sleep disturbances
50%
Tesomet
Sleep disturbances
13%
placebo
Source sentences
Summary
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%).
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439703
02HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome
In adults with hypothalamic obesity, dry mouth occurred in 43% with Tesomet versus 0% with placebo.
In plain wordsIn adults with hypothalamic obesity, dry mouth occurred in 43% with Tesomet and 0% with placebo.
Peptide
Tesofensine
Outcome
IncreaseDry mouth
Study
n = 21
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Measurements
Dry mouth
43%
Tesomet
Dry mouth
0%
placebo
Source sentences
Summary
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%).
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439704
03HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome
In adults with hypothalamic obesity, headache occurred in 36% with Tesomet versus 0% with placebo.
In plain wordsIn adults with hypothalamic obesity, headache occurred in 36% with Tesomet and 0% with placebo.
Peptide
Tesofensine
Outcome
IncreaseHeadache
Study
n = 21
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Nervous system and cognition
Measurements
Headache
36%
Tesomet
Headache
0%
placebo
Source sentences
Summary
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%).
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439705
04HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome
In adults with hypothalamic obesity, heart rate did not differ significantly between Tesomet and placebo.
In plain wordsIn adults with hypothalamic obesity, heart rate did not differ significantly with Tesomet versus placebo.
Peptide
Tesofensine
Outcome
No significant changeHeart rate
Study
n = 18
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Cardiovascular
Source sentences
Summary
No significant differences in heart rate or blood pressure were observed between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439706
05HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome
In adults with hypothalamic obesity, blood pressure did not differ significantly between Tesomet and placebo.
In plain wordsIn adults with hypothalamic obesity, blood pressure did not differ significantly with Tesomet versus placebo.
Peptide
Tesofensine
Outcome
No significant changeBlood pressure
Study
n = 18
Comparator
Placebo
Analysis
Primary
Outcome group
Blood pressure · Cardiovascular
Source sentences
Summary
No significant differences in heart rate or blood pressure were observed between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439707
06HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome
In adults with hypothalamic obesity, one patient had a Tesomet-related serious adverse event of exacerbated pre-existing anxiety that led to treatment discontinuation.
In plain wordsIn adults with hypothalamic obesity, one patient had serious worsening of existing anxiety related to Tesomet and stopped treatment.
Peptide
Tesofensine
Outcome
Direction not reportedSerious anxiety exacerbation
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Mental health and mood
Measurements
Patients with serious anxiety exacerbation
1 patient
Tesomet
Source sentences
Summary
One patient experienced a Tesomet-related SAE of exacerbated pre-existing anxiety leading to treatment discontinuation.
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439701
07HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome
In adults with hypothalamic obesity, more patients achieved ≥5% weight loss with Tesomet than placebo.
In plain wordsIn adults with hypothalamic obesity, more patients lost at least 5% of weight with Tesomet than placebo.
Peptide
Tesofensine
Outcome
IncreaseAt least 5% weight loss
Study
n = 21
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Responders
8 patients
Tesomet 8/13
Responders
1 patients
placebo 1/8
Source sentences
Summary
increased the number of patients achieving ≥5% weight loss (Tesomet 8/13, placebo 1/8; P = 0.046),
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439709
08HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome
In adults with hypothalamic obesity, Tesomet reduced weight more than placebo, with an additional mean change of -6.3%.
In plain wordsIn adults with hypothalamic obesity, Tesomet reduced weight more than placebo.
Peptide
Tesofensine
Outcome
DecreaseWeight change
Study
n = 18
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Additional mean weight change versus placebo
−6.3%
Tesomet versus placebo, 95% CI -11.3 to -1.3, P = 0.017
Source sentences
Summary
Compared to placebo, Tesomet resulted in additional mean (95% CI) weight change of -6.3% ((-11.3; -1.3); P = 0.017),
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439708
09HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome
In adults with hypothalamic obesity, Tesomet tended to augment waist reduction versus placebo, without statistical significance.
In plain wordsIn adults with hypothalamic obesity, Tesomet tended to reduce waist size more than placebo, but the difference was not significant.
Peptide
Tesofensine
Outcome
No significant changeWaist circumference reduction
Study
n = 18
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Measurements
Additional reduction in waist circumference versus placebo
5.7 cm
Tesomet versus placebo, 95% CI -0.1 to 11.5, P = 0.054
Source sentences
Summary
and tended to augment the reduction in waist circumference by 5.7 cm ((-0.1; 11.5); P = 0.054).
2 context sentences(design, population, supporting numbers)
Summary · context
To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.MethodsTwenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks.
Summary · context
The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.
In this study, Tesofensine was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Tesofensine.
Show in the study text Report a problemFND-3529439710

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Version 2Current
21 Oct 2026, 15:58 UTC
Study results updated
Version 1
21 Oct 2026, 12:50 UTC
First added · source update from Europe PMC

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