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

Sponsor
Saniona (Industry)
Overall Status
Suspended
CT.gov ID
NCT05147415
Collaborator
(none)
104
Enrollment
1
Location
4
Arms
29.6
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Other: Placebo
Inactive comparator

Drug: Tesomet
Fixed-dose combination
Other Names:
  • tesofensine
  • metoprolol

    		•
    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

    Drug: Tesomet
    Fixed-dose combination
    Other Names:
  • tesofensine
  • metoprolol

    		•
    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

    Drug: Tesomet
    Fixed-dose combination
    Other Names:
  • tesofensine
  • metoprolol

    		•
    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

    Drug: Tesomet
    Fixed-dose combination
    Other Names:
  • tesofensine
  • metoprolol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Body weight (%) [Baseline to Week 36]

      Percentage change in body weight

    Secondary Outcome Measures

    1. Body weight loss [Week 36]

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

    2. Body weight (kg) [Baseline to Week 36]

      Change in body weight in kilograms

    3. Waist circumference (cm) [Baseline to Week 36]

      Change in waist circumference in centimeters

    4. Body Mass Index (BMI) [Baseline to Week 36]

      Change in BMI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sparrow Clinical Research Institute Lansing Michigan United States 48912

    Sponsors and Collaborators

    • Saniona

    Investigators

    • Study Director: Sophie Guillaume, MS, Saniona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saniona
    ClinicalTrials.gov Identifier:
    NCT05147415
    Other Study ID Numbers:
    • TM008
    First Posted:
    Dec 7, 2021
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity
    Metoprolol

    Study Results

    No Results Posted as of Apr 11, 2022