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Study · Not a test of the peptide alone · 2021

17 results

Weight Loss, Improved Body Composition and Fat Distribution by Tesomet in Acquired Hypothalamic Obesity

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

Journal of the Endocrine Society3 May 2021

PMCIDPMC8089137 (opens in a new tab)PepBankPUB-97954551
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study17

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

Studies that did not test the peptide alone17

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.

  1. 01HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, three serious adverse events occurred in two Tesomet recipients.

    In plain wordsIn adults with hypothalamic obesity, three serious adverse events occurred in two Tesomet recipients.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedSerious adverse events
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Measurements

    Serious adverse events
    3 events
    Tesomet
    Affected participants
    2 participants
    Tesomet

    Source sentences

    Summary
    Three serious adverse events (SAE) were recorded in 2 subjects randomized to Tesomet.
    3 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).
    Summary · context
    Primary endpoint was safety evaluated by change in heart rate, blood pressure and adverse events.

    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.

  2. 02HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, adverse events during the Tesomet trial were otherwise mostly mild.

    In plain wordsIn adults with hypothalamic obesity, adverse events during the Tesomet trial were otherwise mostly mild.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedAdverse event severity
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Measurements

    Mild adverse events
    58%
    trial events, arm attribution unspecified

    Source sentences

    Summary
    Adverse events were otherwise mostly mild (58%), frequently reported were sleep disturbances (62%), dry mouth (46%) and dizziness (46%), known side effects of tesofensine or metoprolol.
    3 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).
    Summary · context
    Primary endpoint was safety evaluated by change in heart rate, blood pressure and adverse events.

    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.

  3. 03HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, sleep disturbances were frequent during the Tesomet trial, with arm attribution unspecified.

    In plain wordsIn adults with hypothalamic obesity, sleep disturbances were frequent during the Tesomet trial, with arm attribution unspecified.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedSleep disturbances
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Sleep · Sleep

    Measurements

    Sleep disturbances
    62%
    trial, arm attribution unspecified

    Source sentences

    Summary
    Adverse events were otherwise mostly mild (58%), frequently reported were sleep disturbances (62%), dry mouth (46%) and dizziness (46%), known side effects of tesofensine or metoprolol.
    3 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).
    Summary · context
    Primary endpoint was safety evaluated by change in heart rate, blood pressure and adverse events.

    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.

  4. 04HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, dry mouth was frequent during the Tesomet trial, with arm attribution unspecified.

    In plain wordsIn adults with hypothalamic obesity, dry mouth was frequent during the Tesomet trial, with arm attribution unspecified.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedDry mouth
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Measurements

    Dry mouth
    46%
    trial, arm attribution unspecified

    Source sentences

    Summary
    Adverse events were otherwise mostly mild (58%), frequently reported were sleep disturbances (62%), dry mouth (46%) and dizziness (46%), known side effects of tesofensine or metoprolol.
    3 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).
    Summary · context
    Primary endpoint was safety evaluated by change in heart rate, blood pressure and adverse events.

    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.

  5. 05HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, dizziness was frequent during the Tesomet trial, with arm attribution unspecified.

    In plain wordsIn adults with hypothalamic obesity, dizziness was frequent during the Tesomet trial, with arm attribution unspecified.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedDizziness
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Nervous system and cognition

    Measurements

    Dizziness
    46%
    trial, arm attribution unspecified

    Source sentences

    Summary
    Adverse events were otherwise mostly mild (58%), frequently reported were sleep disturbances (62%), dry mouth (46%) and dizziness (46%), known side effects of tesofensine or metoprolol.
    3 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).
    Summary · context
    Primary endpoint was safety evaluated by change in heart rate, blood pressure and adverse events.

    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.

  6. 06HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, Tesomet did not significantly change heart rate versus placebo.

    In plain wordsIn adults with hypothalamic obesity, Tesomet did not significantly change heart rate versus placebo.

    Peptide
    Tesofensine
    Outcome
    No significant changeHeart rate
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Heart function · Cardiovascular

    Source sentences

    Summary
    No significant differences in heart rate or blood pressure were observed between the two groups.
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  7. 07HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, Tesomet did not significantly change blood pressure versus placebo.

    In plain wordsIn adults with hypothalamic obesity, Tesomet did not significantly change blood pressure versus placebo.

    Peptide
    Tesofensine
    Outcome
    No significant changeBlood pressure
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Blood pressure · Cardiovascular

    Source sentences

    Summary
    No significant differences in heart rate or blood pressure were observed between the two groups.
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  8. 08HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome

    In adults with hypothalamic obesity, Tesomet reduced body weight more than placebo at week 24.

    In plain wordsIn adults with hypothalamic obesity, Tesomet reduced body weight more than placebo at week 24.

    Peptide
    Tesofensine
    Outcome
    DecreaseWeight loss
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Additional mean weight change
    −6.3%
    Tesomet versus placebo at week 24
    Weight change
    −0.3%
    placebo at week 24

    Source sentences

    Summary
    At week 24, compared to placebo (weight-loss: -0.3%), Tesomet treatment resulted in additional mean weight-loss of -6.3% (95CI [-11.3%; -1.3%], p=0.017)
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  9. 09HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome

    In adults with hypothalamic obesity, more Tesomet recipients achieved greater than 5% weight loss than placebo recipients.

    In plain wordsIn adults with hypothalamic obesity, more Tesomet recipients achieved greater than 5% weight loss than placebo recipients.

    Peptide
    Tesofensine
    Outcome
    IncreaseWeight loss greater than 5%
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Responders
    8 participants
    Tesomet
    Responders
    1 participants
    Placebo
    Odds ratio
    11.2 ratio
    Tesomet versus placebo

    Source sentences

    Summary
    increase in the proportion of patients achieving >5% reduction in body weight (Tesomet 8; Placebo 1, OR 11.2 [1.0; 120.4], p=0.046)
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  10. 10HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome

    In adults with hypothalamic obesity, Tesomet reduced waist circumference versus placebo, but the difference was not statistically significant.

    In plain wordsIn adults with hypothalamic obesity, Tesomet reduced waist circumference versus placebo, but the difference was not statistically significant.

    Peptide
    Tesofensine
    Outcome
    No significant changeWaist circumference
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Waist circumference difference
    −5.7 cm
    Tesomet versus placebo
    P value
    0.054
    between groups

    Source sentences

    Summary
    and reduction in waist circumference of -5.7cm ([-11.5; 0.1], p=0.054).
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  11. 11HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome

    In adults with hypothalamic obesity, Tesomet-associated weight loss correlated with reduced fat mass.

    In plain wordsIn adults with hypothalamic obesity, Tesomet-associated weight loss correlated with reduced fat mass.

    Peptide
    Tesofensine
    Outcome
    DecreaseFat mass
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Mean fat mass change
    −5.3 kg
    Tesomet
    Weight loss correlation r2
    0.9
    fat mass reduction

    Source sentences

    Summary
    Tesomet-induced weight loss was primarily correlated to a reduction in mean (SD) fat mass -5.3kg (5.3) (r2=0.9, P=0001) and to lesser extent a reduction in lean tissue mass -2.9kg (1.9) (r2=0.4, P=0.03).
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  12. 12HumanNot a test of Tesofensine aloneRandomized controlled trialEfficacy outcome

    In adults with hypothalamic obesity, Tesomet-associated weight loss correlated with reduced lean tissue mass.

    In plain wordsIn adults with hypothalamic obesity, Tesomet-associated weight loss correlated with reduced lean tissue mass.

    Peptide
    Tesofensine
    Outcome
    DecreaseLean tissue mass
    Study

    n: not reported in source

    Comparator
    Baseline
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Mean lean tissue mass change
    −2.9 kg
    Tesomet
    Weight loss correlation r2
    0.4
    lean tissue mass reduction

    Source sentences

    Summary
    Tesomet-induced weight loss was primarily correlated to a reduction in mean (SD) fat mass -5.3kg (5.3) (r2=0.9, P=0001) and to lesser extent a reduction in lean tissue mass -2.9kg (1.9) (r2=0.4, P=0.03).
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  13. 13HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, Tesomet did not significantly affect corrected QT interval versus placebo.

    In plain wordsIn adults with hypothalamic obesity, Tesomet did not significantly affect corrected QT interval versus placebo.

    Peptide
    Tesofensine
    Outcome
    No significant changeCorrected QT interval
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Heart function · Cardiovascular

    Measurements

    Corrected QT difference
    −1.1 ms
    Tesomet versus placebo

    Source sentences

    Summary
    Treatment did not affect corrected QT-interval; mean change from placebo was -1.1ms (95CI [-16.0; 13.9], p=0.882), nor were arrythmias registered during the trial period.
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  14. 14HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, no arrhythmias occurred during the Tesomet trial.

    In plain wordsIn adults with hypothalamic obesity, no arrhythmias occurred during the Tesomet trial.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedArrhythmias
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Adverse events · Cardiovascular

    Source sentences

    Summary
    Treatment did not affect corrected QT-interval; mean change from placebo was -1.1ms (95CI [-16.0; 13.9], p=0.882), nor were arrythmias registered during the trial period.
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  15. 15HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, two participants discontinued treatment in each Tesomet and placebo group.

    In plain wordsIn adults with hypothalamic obesity, two participants discontinued treatment in each Tesomet and placebo group.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedTreatment discontinuation
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body

    Measurements

    Discontinuations
    2 participants
    Tesomet
    Discontinuations
    2 participants
    Placebo

    Source sentences

    Summary
    Four subjects, two in each group, discontinued treatment.
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  16. 16HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, one Tesomet recipient discontinued treatment due to anxiety.

    In plain wordsIn adults with hypothalamic obesity, one Tesomet recipient discontinued treatment due to anxiety.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedDiscontinuation due to anxiety
    Study

    n: not reported in source

    Outcome group
    Adverse events · Mental health and mood

    Measurements

    Anxiety discontinuations
    1 participant
    Tesomet

    Source sentences

    Summary
    Tesomet discontinuation was secondary to anxiety (n=1) or dry mouth (n=1).
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

  17. 17HumanNot a test of Tesofensine aloneRandomized controlled trialSafety outcome

    In adults with hypothalamic obesity, one Tesomet recipient discontinued treatment due to dry mouth.

    In plain wordsIn adults with hypothalamic obesity, one Tesomet recipient discontinued treatment due to dry mouth.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedDiscontinuation due to dry mouth
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body

    Measurements

    Dry mouth discontinuations
    1 participant
    Tesomet

    Source sentences

    Summary
    Tesomet discontinuation was secondary to anxiety (n=1) or dry mouth (n=1).
    2 context sentences
    Summary · context
    This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity.
    Summary · context
    Twenty-one (16 females) hypopituitary adults with hypothalamic obesity were randomized to Tesomet or placebo (2:1) for 24 weeks (NCT03845075).

    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    21 Oct 2026, 15:58 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 12:50 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

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