Akkermansia Muciniphila Akk11 Impact on Obesity and Metabolic Health

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT06728098
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in adult obesity.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2025-02-25
• Primary Completion: 2025-05-25
• Study Completion: 2025-09-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total <200 mg/dL; LDL-C <100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride < 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

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Exclusion Criteria

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total <200 mg/dL; LDL-C <100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride < 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	84 days	The primary outcome measure is the change in body weight from baseline to the end of the study period. This will be quantified by the difference in weight measurements taken at the start and end of the study for each participant in the obese patient group receiving Akkermansia muciniphila Akk11, and compared to those in the placebo group and the healthy adult control group.

Trial Locations

Locations (1)

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia