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

December 9, 2022 updated by: Saniona

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight (%)
Time Frame: Baseline to Week 36
Percentage change in body weight
Baseline to Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight loss
Time Frame: Week 36
Proportion of subjects who meet pre-specified thresholds for body weight loss
Week 36
Body weight (kg)
Time Frame: Baseline to Week 36
Change in body weight in kilograms
Baseline to Week 36
Waist circumference (cm)
Time Frame: Baseline to Week 36
Change in waist circumference in centimeters
Baseline to Week 36
Body Mass Index (BMI)
Time Frame: Baseline to Week 36
Change in BMI
Baseline to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saniona

Investigators

  • Study Director: Sophie Guillaume, MS, Saniona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TM008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Sponsor will consider requests from qualified researchers for access to TM008 study materials

IPD Sharing Time Frame

Following completion of Tesomet clinical development

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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