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

What Was Tested

This registered phase 2 trial tested Tesofensine (non-peptide).

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.

It had two arms (groups): active arm (experimental) and placebo arm (placebo comparator).

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

The registry classes the interventions as drug.

More on the Plan

The placebo arm will receive matching placebo tablets.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Tesofensine (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tesofensine (non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Tesofensine (non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-02-25 with completion listed for 2020-10-16.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Treatment Emergent Adverse Events (time frame: from Baseline to week 24). Number of Participants With at Least One Mild, Moderate or Severe Adverse Event (time frame: from Baseline to week 24). Participants (Number and Percentage) With and Type of Serious Adverse Events (time frame: from Baseline to week 24).

It also tracked 17 secondary outcomes, for example Composite Satiety Score (CSS), Body Weight, Body Composition - Fat Mass, Body Composition - Lean Body Mass, Glycemic Control - HbA1c and Glycemic Control - Fasting Plasma Glucose.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesofensine (non-peptide) in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tesofensine (non-peptide) compound page, all human trials.