Phase 2
Completed N=22
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Hypothalamic Injury-induced Obesity (HIO)
Source: ClinicalTrials.gov NCT03845075 ↗
Enrolled (actual)
22
Serious AEs
10.3%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events — 12; 7 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events |
12; 7 | — |
| PRIMARY Number of Participants With at Least One Mild, Moderate or Severe Adverse Event |
11; 7; 10; 5; 2; 2 | — |
| PRIMARY Participants (Number and Percentage) With and Type of Serious Adverse Events |
2; 1; 1; 0; 1; 0 | — |
| PRIMARY Safety as Assessed by Systolic Blood Pressure [mmHg] |
124.0; 134.5; 126.6; 131.8; 129.2; 126.3 | 0.4671 |
| PRIMARY Safety as Assessed by Diastolic Blood Pressure [mmHg] |
83.2; 85.9; 84.2; 86.8; 84.5; 86.0 | 0.6543 |
| PRIMARY Safety as Assessed by Heart Rate [Bpm] |
75.5; 78.9; 71.9; 75.9; 72.7; 76.0 | 0.7023 |
| PRIMARY Safety as Assessed by Hematology Parameters |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Safety as Assessed by Electrolytes and Creatinine |
0; 0; 2; 2; 0; 0 | — |
| PRIMARY Safety as Assessed by Liver and Kidney Function Tests |
0; 0; 5; 1; 0; 1 | — |
| SECONDARY Composite Satiety Score (CSS) |
4.5; 6.5; 4.2; 11.2; -0.3; 4.7 | 0.7782 |
| SECONDARY Body Weight |
-7.93; -0.15; -6.53; -5.65; 1.40; -5.50 | 0.0325 sig |
| SECONDARY Body Composition - Fat Mass |
-5.31; -1.04; -4.87; -3.77; 0.44; -2.73 | 0.1048 |
| SECONDARY Body Composition - Lean Body Mass |
-2.85; 0.55; -1.81; -1.87; 1.04; -2.42 | 0.0033 sig |
| SECONDARY Glycemic Control - HbA1c |
-6.00; -0.17; -5.33; -0.17; 0.67; 0.00 | 0.0713 |
| SECONDARY Glycemic Control - Fasting Plasma Glucose |
-0.29; -0.28; -0.11; 0.08; 0.18; 0.37 | 0.7926 |
| SECONDARY Craving for Something Sweet, Salty, Meat/Fish, or Fatty |
9.0; 16.2; 2.1; 35.3; -6.9; 19.2 | 0.0905 |
| SECONDARY Thirst |
-2.4; -18.8; -6.3; -16.7; -3.8; 2.2 | 0.8082 |
| SECONDARY Waist Circumference |
-7.08; -1.17; -5.75; -3.00; 1.33; -1.83 | 0.0537 |
| SECONDARY Lipid Profile |
-0.17; -0.17; -0.01; -0.22; 0.16; -0.05 | 0.8623 |
| SECONDARY Quality of Life - SF-36 |
0.90; 1.36; 0.70; 2.41; -0.21; 1.05 | 0.8420 |
| SECONDARY Number of Participants With Adverse Event(s) and/or Serious Adverse Event(s) - Open-label Extension |
6; 4; 5; 3; 7; 1 | — |
| SECONDARY Blood Pressure (Change) |
2.0; -4.2; 5.8; -9.7; 5.0; -5.5 | 0.3037 |
| SECONDARY 24 Hours Blood Pressure |
-8.0; 0.7; 2.3; -8.4; 0.2; 3.7 | 0.8728 |
| SECONDARY Plasma Trough Concentrations |
12.03; 12.34; 11.01; 19.10; 6.78; 15.11 | — |
| SECONDARY 48 Hours Heart Rate and QT Interval at Baseline, Week 12 and Week 24 |
14; 8; 0; 0; 9; 6 | — |
| SECONDARY Heart Rate (Change) |
-2.4; -7.0; 0.1; 0.7; 4.2; 7.7 | 0.5551 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03845075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.