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Study · Not a test of the peptide alone · 2022

14 results

ODP350 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

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Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9625380 (opens in a new tab)PepBankPUB-90221884
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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 study14

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

Studies that did not test the peptide alone14

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 trialEfficacy outcome

    In adults with hypothalamic obesity, Tesomet reduced weight more than placebo during the double-blind period.

    In plain wordsIn adults with hypothalamic obesity, Tesomet reduced weight more than placebo during the double-blind period.

    Peptide
    Tesofensine
    Outcome
    DecreaseDouble-blind weight change
    Study

    n: not reported in source

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

    Measurements

    Weight change
    −7.84 kg
    Tesomet
    Weight change
    −0.34 kg
    placebo

    Source sentences

    Summary
    On completion of the double-blind period mean change in body weight (kg) was -7.84 for the Tesomet group versus -0.34 kg for the placebo group (P=0. 03).
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 trialEfficacy outcome

    In adults with hypothalamic obesity, waist change did not differ significantly between Tesomet and placebo during the double-blind period.

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

    Peptide
    Tesofensine
    Outcome
    No significant changeDouble-blind waist circumference change
    Study

    n: not reported in source

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

    Measurements

    Mean waist circumference change
    −1.16 cm
    placebo

    Source sentences

    Summary
    On completion of the double-blind period mean change in waist circumference (cm) was -7. 09 cm for the Tesomet group versus -1.16 for the placebo group (P=NS).
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 trialEfficacy outcome

    In adults with hypothalamic obesity, fat mass change did not differ significantly between Tesomet and placebo during the double-blind period.

    In plain wordsIn adults with hypothalamic obesity, fat mass change did not differ significantly with Tesomet versus placebo.

    Peptide
    Tesofensine
    Outcome
    No significant changeDouble-blind fat mass change
    Study

    n: not reported in source

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

    Measurements

    Fat mass change
    −5.28 kg
    Tesomet
    Fat mass change
    −1.11 kg
    placebo

    Source sentences

    Summary
    On completion of the double-blind period mean change in fat mass (kg) was -5.28 for the Tesomet group versus -1.11 for the placebo group (P=NS).
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 trialEfficacy outcome

    In adults with hypothalamic obesity, Tesomet reduced lean tissue mass more than placebo during the double-blind period.

    In plain wordsIn adults with hypothalamic obesity, Tesomet reduced lean tissue mass more than placebo.

    Peptide
    Tesofensine
    Outcome
    DecreaseDouble-blind lean tissue mass change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Musculoskeletal

    Measurements

    Lean tissue mass change
    −2.76 kg
    Tesomet
    Lean tissue mass change
    0.36 kg
    placebo

    Source sentences

    Summary
    On completion of the double-blind period mean change in lean tissue mass (kg) was -2.76 for the Tesomet group versus 0.36 for the placebo group (P<0. 01).
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialSafety outcome

    In adults with hypothalamic obesity, sleep disorder was among the common adverse events during Tesomet treatment periods.

    In plain wordsIn adults with hypothalamic obesity, sleep disorder was a common adverse event during Tesomet treatment periods.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedSleep disorder
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Sleep

    Source sentences

    Summary
    The most common adverse events following the 24-week double-blind period and the 24-week open-label extension period were sleep disorder, dizziness, dry mouth, and headache; the majority of these adverse events were mild to moderate in severity.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialSafety outcome

    In adults with hypothalamic obesity, dizziness was among the common adverse events during Tesomet treatment periods.

    In plain wordsIn adults with hypothalamic obesity, dizziness was a common adverse event during Tesomet treatment periods.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedDizziness
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Nervous system and cognition

    Source sentences

    Summary
    The most common adverse events following the 24-week double-blind period and the 24-week open-label extension period were sleep disorder, dizziness, dry mouth, and headache; the majority of these adverse events were mild to moderate in severity.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialSafety outcome

    In adults with hypothalamic obesity, dry mouth was among the common adverse events during Tesomet treatment periods.

    In plain wordsIn adults with hypothalamic obesity, dry mouth was a common adverse event during Tesomet treatment periods.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedDry mouth
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    The most common adverse events following the 24-week double-blind period and the 24-week open-label extension period were sleep disorder, dizziness, dry mouth, and headache; the majority of these adverse events were mild to moderate in severity.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialSafety outcome

    In adults with hypothalamic obesity, headache was among the common adverse events during Tesomet treatment periods.

    In plain wordsIn adults with hypothalamic obesity, headache was a common adverse event during Tesomet treatment periods.

    Peptide
    Tesofensine
    Outcome
    Direction not reportedHeadache
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Nervous system and cognition

    Source sentences

    Summary
    The most common adverse events following the 24-week double-blind period and the 24-week open-label extension period were sleep disorder, dizziness, dry mouth, and headache; the majority of these adverse events were mild to moderate in severity.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialSafety outcome

    In adults with hypothalamic obesity, heart rate showed no significant or clinically meaningful change during the Tesomet study.

    In plain wordsIn adults with hypothalamic obesity, heart rate did not change significantly or meaningfully during the Tesomet study.

    Peptide
    Tesofensine
    Outcome
    No significant changeHeart rate change
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Cardiovascular

    Source sentences

    Summary
    No significant nor clinically meaningful changes in heart rate or blood pressure were observed during the study.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialSafety outcome

    In adults with hypothalamic obesity, blood pressure showed no significant or clinically meaningful change during the Tesomet study.

    In plain wordsIn adults with hypothalamic obesity, blood pressure did not change significantly or meaningfully during the Tesomet study.

    Peptide
    Tesofensine
    Outcome
    No significant changeBlood pressure change
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Blood pressure · Cardiovascular

    Source sentences

    Summary
    No significant nor clinically meaningful changes in heart rate or blood pressure were observed during the study.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialEfficacy outcome

    In adults with hypothalamic obesity, weight remained below baseline in both treatment sequences after the Tesomet extension.

    In plain wordsIn adults with hypothalamic obesity, both treatment sequences had lower weight than baseline after the Tesomet extension.

    Peptide
    Tesofensine
    Outcome
    DecreaseExtension weight change
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Mean body weight change from baseline
    −6.34 kg
    Tesomet-Tesomet group

    Source sentences

    Summary
    At the end of the open-label extension period mean change in body weight (kg) from baseline was -6.34 for the Tesomet-Tesomet group and -6. 03 for the placebo-Tesomet group.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialEfficacy outcome

    In adults with hypothalamic obesity, waist circumference remained below baseline in both treatment sequences after the Tesomet extension.

    In plain wordsIn adults with hypothalamic obesity, both treatment sequences had smaller waists than baseline after the Tesomet extension.

    Peptide
    Tesofensine
    Outcome
    DecreaseExtension waist circumference change
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Mean waist circumference change from baseline
    −5.73 cm
    Tesomet-Tesomet group

    Source sentences

    Summary
    At the end of the open-label extension period mean change in waist circumference (cm) from baseline was -5.73 for the Tesomet-Tesomet group and -3. 04 for the placebo-Tesomet group.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialEfficacy outcome

    In adults with hypothalamic obesity, fat mass remained below baseline in both treatment sequences after the Tesomet extension.

    In plain wordsIn adults with hypothalamic obesity, both treatment sequences had less fat mass than baseline after the Tesomet extension.

    Peptide
    Tesofensine
    Outcome
    DecreaseExtension fat mass change
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Fat mass change
    −4.84 kg
    Tesomet-Tesomet
    Fat mass change
    −3.85 kg
    placebo-Tesomet

    Source sentences

    Summary
    At the end of the open-label extension period mean change in fat mass (kg) from baseline was -4.84 for the Tesomet-Tesomet group and -3.85 for the placebo-Tesomet group.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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 aloneNon-randomized trialEfficacy outcome

    In adults with hypothalamic obesity, lean mass remained below baseline in both treatment sequences after the Tesomet extension.

    In plain wordsIn adults with hypothalamic obesity, both treatment sequences had less lean mass than baseline after the Tesomet extension.

    Peptide
    Tesofensine
    Outcome
    DecreaseExtension lean mass change
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Body weight · Musculoskeletal

    Measurements

    Lean mass change
    −1.64 kg
    Tesomet-Tesomet
    Lean mass change
    −2.22 kg
    placebo-Tesomet

    Source sentences

    Summary
    At the end of the open-label extension period mean change in lean mass (kg) from baseline was -1.64 for the Tesomet-Tesomet group and -2.22 for the placebo-Tesomet group.
    4 context sentences
    Summary · context
    To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy.
    Summary · context
    Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period.
    Summary · context
    On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet.
    Summary · context
    The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition.

    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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