48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)

Saniona

Status and phase: Completed; Phase 2

Conditions: Hypothalamic Injury-induced Obesity (HIO)

Treatments: Drug: Placebo; Drug: Tesofensine/Metoprolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03845075

TM005

Details and patient eligibility

About

Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period.

• The study will have two parts:

• Part 1: 24 weeks double-blind treatment (DB), followed by
• Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator

Full description

Part 1 - the double-blind (DB) part: The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. The placebo arm will receive matching placebo tablets.

Part 2 - the open-label extension (OLE) part: All active participants at the end of the double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities
• Males and females, aged 18-75
• Confirmed diagnosis of HIO
• BMI ≥27 kg/m2 (where overweight is related to the HIO)

Exclusion criteria

• Blood Pressure (BP) ≥160/90 mmHg
• Heart rate (HR) ≥ 90, <50 bpm
• Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or Prader-Willi syndrome
• Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
• Previous myocardial infarction or stroke within the last 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

active arm

Experimental group

Description:

The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

Treatment:

Drug: Tesofensine/Metoprolol

placebo arm

Placebo Comparator group

Description:

The placebo arm will receive matching placebo tesofensine and placebo metoprolol.

Treatment:

Drug: Placebo