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

NCT ID: NCT05147415

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-12-09

Brief Summary

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

Detailed Description

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Conditions

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Hypothalamic Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Inactive comparator

Tesomet

Intervention Type DRUG

Fixed-dose combination

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

Group Type EXPERIMENTAL

Tesomet

Intervention Type DRUG

Fixed-dose combination

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

Group Type EXPERIMENTAL

Tesomet

Intervention Type DRUG

Fixed-dose combination

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

Group Type EXPERIMENTAL

Tesomet

Intervention Type DRUG

Fixed-dose combination

Interventions

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Placebo

Inactive comparator

Intervention Type OTHER

Tesomet

Fixed-dose combination

Intervention Type DRUG

Other Intervention Names

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tesofensine metoprolol

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saniona

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Guillaume, MS

Role: STUDY_DIRECTOR

Saniona

Locations

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Sparrow Clinical Research Institute

Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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TM008

Identifier Type: -

Identifier Source: org_study_id