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Trial · Interventional

WithdrawnPhase 2Registry data

Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
Saniona · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
11 Nov 2021
Primary completion
9 Dec 2022
Completion
9 Dec 2022
First posted
7 Dec 2021
Last update posted
13 Dec 2022
Conditions
Hypothalamic Obesity

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

    Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)

    NCT05147415

    11 Nov 2021 to 9 Dec 2022

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO

Interventions

  • PlaceboOther
  • TesometDrug

Arms4

  • Placebo comparator

    Placebo

    Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated Tesomet dose from the double-blind period

  • Experimental

    Tesomet Low Dose

    Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period

  • Experimental

    Tesomet Medium Dose

    Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period

  • Experimental

    Tesomet High Dose

    Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Body weight (%)

    Time frame · Baseline to Week 36

    Registry description

    Percentage change in body weight

Secondary outcomes(4)
  1. Body weight loss

    Time frame · Week 36

    Registry description

    Proportion of subjects who meet pre-specified thresholds for body weight loss

  2. Body weight (kg)

    Time frame · Baseline to Week 36

    Registry description

    Change in body weight in kilograms

  3. Waist circumference (cm)

    Time frame · Baseline to Week 36

    Registry description

    Change in waist circumference in centimeters

  4. Body Mass Index (BMI)

    Time frame · Baseline to Week 36

    Registry description

    Change in BMI

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: * Subject and, if applicable, their parent or legal guardian must be willing to provide informed consent * Diagnosis of HO secondary to damage to the hypothalamus * Female subjects must be of non-childbearing potential * At least 6 months since completion of therapy (chemotherapy, surgery, or radiation with resulting injury to the hypothalamus and/or the pituitary) with stable disease and lack of recurrence * BMI 30.0 to 60.0 kg/m², inclusive * Documented stable body weight (gain/loss \<10%) for at least 90 days prior to Screening * Stable and well-managed pituitary replacement (eg, glucocorticoid, thyroid hormone, estrogen/progestin or testosterone, desmopressin, or growth hormone) for \>2 months prior to Screening * Male subjects who are sexually active must be surgically sterile Key Exclusion Criteria: * Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study * Sitting BP that meets the following criteria after 5 minutes of rest at Screening: 1. Systolic BP \>145 mmHg or \<100 mmHg; or 2. Diastolic BP \>95 mmHg or \<70 mmHg * Type 1 diabetes mellitus * History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder) * Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism) * History of bulimia or anorexia nervosa * Use of prohibited medications, including current use of selective serotonin reuptake inhibitors / serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)

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