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

NCT05147415 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: TM008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothalamic Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight (%)

  Percentage change in body weight

  Baseline to Week 36

Secondary Outcomes (4)

• Body weight loss

  Week 36

• Body weight (kg)

  Baseline to Week 36

• Waist circumference (cm)

  Baseline to Week 36

• Body Mass Index (BMI)

  Baseline to Week 36

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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; Drug: Tesomet

Tesomet Low Dose

EXPERIMENTAL

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

Tesomet Medium Dose

EXPERIMENTAL

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

Tesomet High Dose

EXPERIMENTAL

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

Interventions

Placebo OTHER

Inactive comparator

Placebo

Tesomet DRUG

Fixed-dose combination

Also known as: tesofensine, metoprolol

Placebo; Tesomet High Dose; Tesomet Low Dose; Tesomet Medium Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Systolic BP \>145 mmHg or \<100 mmHg; or
• 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)

Sponsors & Collaborators

• Saniona: lead

Study Sites (1)

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

MeSH Terms

Conditions

Sexual Infantilism

Interventions

Tesofensine; Metoprolol

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hypogonadism

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Sophie Guillaume, MS

  Saniona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: November 11, 2021
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following completion of Tesomet clinical development

Locations

US (1)