N/A for Underweight

Inclusion criteria

• {"criterion_text":"- Participant must be able to understand the requirements of the study and give written informed consent prior to the study start.\n- Females and males aged between 65 and 85 years (both inclusive).\n- BMI at baseline 20 (kg/m2) or less\n- 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\n- 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

• {"criterion_text":"- Any contraindication as per summary of product characteristics of any local anesthetics"}
• {"criterion_text":"- Abnormal TSH levels (≥ 4.0 mU/L)"}
• {"criterion_text":"- History of severe allergic or anaphylactic reactions to local anesthetics"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Current intake of any antacids (e.g., Calcium Carbonate, Magnesium Hydroxide, Aluminum Hydroxide, Sodium Bicarbonate, Magnesium Trisilicate)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Excessive alcohol intake (≥ 14 units / week)."}
• {"criterion_text":"- Major abdominal surgery interfering with gastrointestinal function, at the discretion of the study investigator (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- A participant practicing a vegetarian or vegan diet"}
• {"criterion_text":"- Any food allergy or food intolerance (except lactose, gluten, fructose, histamine)"}
• {"criterion_text":"- Impaired renal function (eGFR < 45 ml/min at the discretion of the study investigator)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Impaired hepatic function (transaminase levels > 2 times higher than upper limit of normal)"}
• {"criterion_text":"- Hypotension (diastolic blood pressure ≤ 60 mmHg)"}
• {"criterion_text":"- Participant with uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg)"}
• {"criterion_text":"- Clinically significant abnormal ECG (at the discretion of the study investigator)"}
• {"criterion_text":"- Increased methemoglobin level (≥ 3%)"}
• {"criterion_text":"- Participant with uncontrolled diabetes type I or II."}
• {"criterion_text":"- History of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD Grade ≥ 2)."}
• {"criterion_text":"- Participants with a history or current congestive heart failure"}
• {"criterion_text":"- Participants with malignancies or lymphoproliferative disorders within previous 5 years (except for basal cell carcinoma)"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in the weight of food intake of a standardized lunch on treatment day 1.","definition_or_measurement_approach":"Measured as change from baseline in the weight of food intake of a standardized lunch on treatment day 1."}
• {"endpoint_text":"- Change from baseline in the weight of food intake of a standardized lunch on treatment day 42.","definition_or_measurement_approach":"Measured as change from baseline in the weight of food intake of a standardized lunch on treatment day 42."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in the weight of food intake of a standardized lunch over time (i.e., on treatment days 7 and 14).","definition_or_measurement_approach":"Measured as change from baseline in the weight of food intake of a standardized lunch on treatment days 7 and 14."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured using VAS scores for appetite sensations before and after consumption of a standardized lunch on treatment days 1, 7, 14, and 42."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Measured using VAS scores for GI symptoms before and after consumption of a standardized lunch on treatment days 1, 7, 14, and 42."}
• {"endpoint_text":"- Change from baseline in body weight over time (i.e., on treatment days 1, 7, 14, and 42)","definition_or_measurement_approach":"Measured as change from baseline in body weight on treatment days 1, 7, 14, and 42."}
• {"endpoint_text":"- SF-6D score over time (at baseline and on treatment day 42).","definition_or_measurement_approach":"Measured using SF-6D at baseline and on treatment day 42."}
• {"endpoint_text":"- PGI-S score over time (at baseline and on treatment day 42).","definition_or_measurement_approach":"Measured using PGI-S at baseline and on treatment day 42."}
• {"endpoint_text":"- PGI-I score on treatment day 42.","definition_or_measurement_approach":"Measured using PGI-I on treatment day 42."}
• {"endpoint_text":"- Occurrence of Treatment-Emergent AEs up to end of study.","definition_or_measurement_approach":"Safety endpoint: recording occurrence of treatment-emergent adverse events through end of study."}
• {"endpoint_text":"- Occurrence of Treatment-Emergent SAEs up to end of study.","definition_or_measurement_approach":"Safety endpoint: recording occurrence of treatment-emergent serious adverse events through end of study."}

Netherlands

Earliest CTIS Part Ii Submission Date

29-01-2025

Latest Decision Or Authorization Date

12-02-2025

Processing Time Days

14

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Orexa B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Contract research organisations

Name

Clinfidence B.V.

Responsibilities

[6,7,8]

Name

Harmony Clinical Research

Responsibilities

[1,12,13,5]

Name

Staburo GmbH

Responsibilities

[10,11]

Third parties

• {"country":"Spain","full_name":"Kymos S.L.","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Zwiers Regulatory Consultancy B.V.","duties_or_roles":"[8]","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Clinfidence B.V.","duties_or_roles":"[6,7,8]","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Staburo GmbH","duties_or_roles":"[10,11]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"Harmony Clinical Research","duties_or_roles":"[1,12,13,5]","organisation_type":"Pharmaceutical company"}