A trial to test whether ORE-001 (oral lidocaine) leads to increased food intake and improved health and wellbeing in elderly underweight people

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Orexa B.V.

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

17 Feb 2025 → ongoing

Decision date (initial)

2025-02-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

To evaluate the efficacy of oral ORE-001, in comparison to placebo, in increasing the amount of food intake of a standardized lunch on day 1 and day 42

Secondary objectives 6

1. To further evaluate the efficacy of oral ORE-001, in comparison to placebo, in increasing the amount of food intake during standardized lunch
2. To evaluate the efficacy of oral ORE-001, in comparison to placebo, in reducing satiety and postprandial fullness after the consumption of a standardized lunch
3. To evaluate the effects of oral ORE-001, in comparison to placebo, in changing GI symptoms after the consumption of a standardized lunch
4. To evaluate the efficacy of oral ORE-001, in comparison to placebo, in inducing weight gain
5. To evaluate the changes in patient-reported well-being and Quality of Life
6. To evaluate the safety and tolerability of oral ORE-001

Conditions and MedDRA coding

Underweight

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant must be able to understand the requirements of the study and give written informed consent prior to the study start.
2. Females and males aged between 65 and 85 years (both inclusive).
3. BMI at baseline 20 (kg/m2) or less
4. Male participants enrolled in this study must take appropriate precautions to prevent pregnancy in their female partners of childbearing potential during the study period. To minimize the risk of pregnancy, participants and their partners are required to use one of the following medically approved contraceptive methods throughout the study: -Hormonal contraception (e.g., oral contraceptive pills, vaginal ring, contraceptive injection, contraceptive implant, or intrauterine device [IUD]). -Female sterilization (e.g., bilateral tubal occlusion or tubal ligation). -Male sterilization (vasectomy). Participants must commit to adhering to one of these methods and are also required to abstain from sperm donation for the duration of the study. The study investigator will provide guidance on the most appropriate contraceptive measures based on individual circumstances. Participants should discuss these requirements with their partners to ensure compliance. These measures do not apply if female partner is postmenopausal
5. If a participant's female partner becomes pregnant during the study, the participant must seek her consent to notify the study investigator. If the partner provides consent, the pregnancy will be monitored closely, and relevant clinical data regarding the pregnancy's course and outcome may be obtained from healthcare providers to ensure appropriate follow-up. Additionally, the pregnancy will be reported to the study sponsor in accordance with regulatory requirements. No data will be collected or disclosed without the pregnant partner’s informed consent.

Exclusion criteria 24

1. Any contraindication as per summary of product characteristics of any local anesthetics
2. Abnormal TSH levels (≥ 4.0 mU/L)
3. History of severe allergic or anaphylactic reactions to local anesthetics
4. Current intake of any drugs qualifying as class 1B antiarrhythmic drugs (e.g., Lidocaine, Mexiletine, Phenytoin) and as any class 3 antiarrhythmic drugs - Potassium channel blockers (e.g., Amiodarone, Dronedarone, Sotalol, Ibutilide, Dofetilide, Bretylium), irrespective of the indication for the drug.
5. Current intake of any antacids (e.g., Calcium Carbonate, Magnesium Hydroxide, Aluminum Hydroxide, Sodium Bicarbonate, Magnesium Trisilicate)
6. Significant (at the discretion of the study investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with the need for systemic antibiotic or antimycotic treatment) within the past 2 weeks prior to study medication administration.
7. Excessive alcohol intake (≥ 14 units / week).
8. Major abdominal surgery interfering with gastrointestinal function, at the discretion of the study investigator (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed)
9. Dieting one month or less prior to screening, particularly the practice of regulating or restricting types and amounts of food consumed to achieve or maintain a particular health outcome (e.g. weight management), including structured plans like low-carb diets, low-fat diets, intermittent fasting, balanced diets (e.g., Mediterranean), and other specialized dietary regimens
10. A participant practicing a vegetarian or vegan diet
11. Any food allergy or food intolerance (except lactose, gluten, fructose, histamine)
12. Impaired renal function (eGFR < 45 ml/min at the discretion of the study investigator)
13. Any experimental agent within 30 days or 5 half-lives, whichever is longer, prior to study medication administration or participation in another clinical trial that overlaps with the duration of the present trial.
14. A participants with any familial or close personal relationship with the study investigator or persons working at the respective Investigational Site or participants who are an employee of the Sponsor
15. A participant who is highly likely not able to comply with the protocol requirements and to complete the study in the opinion of the study investigator
16. Impaired hepatic function (transaminase levels > 2 times higher than upper limit of normal)
17. Hypotension (diastolic blood pressure ≤ 60 mmHg)
18. Participant with uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg)
19. Clinically significant abnormal ECG (at the discretion of the study investigator)
20. Increased methemoglobin level (≥ 3%)
21. Participant with uncontrolled diabetes type I or II.
22. History of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD Grade ≥ 2).
23. Participants with a history or current congestive heart failure
24. Participants with malignancies or lymphoproliferative disorders within previous 5 years (except for basal cell carcinoma)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Change from baseline in the weight of food intake of a standardized lunch on treatment day 1.
2. Change from baseline in the weight of food intake of a standardized lunch on treatment day 42.

Secondary endpoints 9

1. Change from baseline in the weight of food intake of a standardized lunch over time (i.e., on treatment days 7 and 14).
2. Change from baseline in VAS scores for appetite sensations in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14, and 42)
3. Change from baseline in VAS scores for GI symptoms in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14 and 42).
4. Change from baseline in body weight over time (i.e., on treatment days 1, 7, 14, and 42)
5. SF-6D score over time (at baseline and on treatment day 42).
6. PGI-S score over time (at baseline and on treatment day 42).
7. PGI-I score on treatment day 42.
8. Occurrence of Treatment-Emergent AEs up to end of study.
9. Occurrence of Treatment-Emergent SAEs up to end of study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Orexa B.V.

Sponsor organisation

Orexa B.V.

Address

Berghemseweg 8

City

Herpen

Postcode

5373 KH

Country

Netherlands

Scientific contact point

Organisation

Orexa B.V.

Contact name

Ard Peeters

Public contact point

Organisation

Orexa B.V.

Contact name

Ard Peeters

Third parties 5

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications