sodium glycocholate; sodium butyrate for Postoperative obesity

Inclusion criteria

• {"criterion_text":"- Provision of signed and dated, written informed consent prior to any study specific procedures.\n- Healthy female and male subjects ≥20 years of age ≤65 years of age.\n- Healthy operated patients with RYGB >12 months ago on daily micronutrient substitution free from medicines (medicines for steady state medical conditions allowed) with normal blood calcium, vitamin D and calcium supplementation and ability to take BAFA\n- Have a steady weight phase (weight within 5 kg variation within last 3 months) and a body mass index from ≥ 20 to ≤ 45 kg/m2\n- Females must have a negative pregnancy test and use anticonceptives.\n- Subjects must be able to understand and willing to comply with study procedures, restrictions and requirements as judged by the investigator."}

Exclusion criteria

• {"criterion_text":"- Women with a positive pregnancy test on enrolment or lactating women.\n- History of hypersensitivity and allergy, as judged by the investigator\n- Subjects not tolerating injections.\n- Complicated RYGB (for example failed primary operation or severe postop complications that affect GI function)), other previous surgeries in the abdomen (appendectomy/cholecystectomy allowed) or severe abdominal complaints.\n- Subjects not tolerating taste of IMP\n- Have previous (<12 months) treatments that may have had impact on bone metabolism.\n- Have other conditions that make principal investigator insecure on study participation.\n- Involvement in the planning, and/or conduct of the study\n- Previous enrolment or randomization in the present study\n- Participation in another clinical study with an IMP during the last 3 months prior to enrolment.\n- History of any unstable medical disease which may interact with the objective of the study or with the safety of the subject, as judged by the investigator\n- History of any psychiatric disease that could preclude reliable participation in the study, as judged by the investigator.\n- Clinically significant illness within 2 weeks before the administration of the IMP as judged by the investigator.\n- Donation of plasma from 2 weeks before Visit 1 or donation of blood from 3 months from Visit 1.\n- Abnormal vital signs, laboratory test value or ECG of clinical significance, as judged by the investigator.\n- Immunisation with live vaccine within the previous 3 months, for other vaccines within the past 30 days.\n- Subjects with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.\n- History of alcohol or drug abuse within 2 years of entering the study\n- History of positive test of covid-19 and as judged by the investigator."}

Primary endpoints

• {"endpoint_text":"- Safety and tolerability","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- PTH concentrations","definition_or_measurement_approach":""}
• {"endpoint_text":"- Ca urinary excretion during 24 h","definition_or_measurement_approach":""}
• {"endpoint_text":"- Bone resorption markers P1NP, CTX and BALP","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

10-05-2024

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

474

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden