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

NCT03845075 | Completed Phase 2 Results

• 1 other identifier: TM005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothalamic Injury-induced Obesity (HIO)

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Treatment Emergent Adverse Events

  Number and percentage of participants with adverse events in each of the two treatment arms

  from Baseline to week 24

• Number of Participants With at Least One Mild, Moderate or Severe Adverse Event

  Number and percentage of participants with mild, moderate or severe adverse events in each of the two treatment arms.

  from Baseline to week 24

• Participants (Number and Percentage) With and Type of Serious Adverse Events

  Number and percentage of participants with at least one serious adverse event, indicating type, in each of the two treatment arms

  from Baseline to week 24

• Safety as Assessed by Systolic Blood Pressure [mmHg]

  Systolic blood pressure in mmHg measured at each visit in each of the two treatment arms

  from Baseline to week 24

• Safety as Assessed by Diastolic Blood Pressure [mmHg]

  Diastolic blood pressure in mmHg measured at each visit in each of the two treatment arms

  from Baseline to week 24

• Safety as Assessed by Heart Rate [Bpm]

  Heart rate measured in beats per minute (bpm) at each visit in each of the two treatment arms

  from Baseline to week 24

• Safety as Assessed by Hematology Parameters

  Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for hemoglobin, platelet counts, white cells count, differential counts at baseline, week 12 and week 24 in each of the two treatment arms

  from Baseline to week 24

• Safety as Assessed by Electrolytes and Creatinine

  Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for sodium, potassium, creatinine at each visit in each of the two treatment arms

  from Baseline to week 24

• Safety as Assessed by Liver and Kidney Function Tests

  Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for gamma glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), glomerular filtration rate (GFR), and urea at baseline, week 12, and week 24 in each of the two treatment arms

  from Baseline to week 24

Secondary Outcomes (17)

• Composite Satiety Score (CSS)

  from baseline to week 24, from baseline to week 48 and from week 24 to week 48

• Body Weight

  from baseline to week 24, from baseline to week 48 and from week 24 to week 48

• Body Composition - Fat Mass

  from baseline to week 24, from baseline to week 48 and from week 24 to week 48

• Body Composition - Lean Body Mass

  from baseline to week 24, from baseline to week 48 and from week 24 to week 48

• Glycemic Control - HbA1c

  from baseline to week 24, from baseline to week 48 and from week 24 to week 48

Study Arms (2)

active arm

EXPERIMENTAL

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

Drug: Tesofensine/Metoprolol

placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tesofensine/Metoprolol DRUG

During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication)

active arm

Placebo DRUG

During Part 1 subjects will be randomized to matching placebo tesofensine and placebo metoprolol

placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Saniona: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 210, Denmark

Location

MeSH Terms

Interventions

Tesofensine; Metoprolol

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Janus Schreiber Larsen
• Organization: Saniona A/S

janus.larsen@saniona.com

7070 5225

Study Officials

• Ulla Feldt-Rasmussen, MD, DMSc

  Department of Medical Endocrinology and metabolism Rigshospitalet,Copenhagen, DK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 30, 2019
• First Posted: February 19, 2019
• Study Start: February 25, 2019
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)