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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• Aged 40-60 years (inclusive), regardless of gender;

• Patients diagnosed with hypercholesterolemia (5.2 mmol/L ≤ TC \<6.2 mmol/L, or 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L), with or without hypertriglyceridemia (1.7 mmol/L ≤ TG \<4.5 mmol/L) or mixed hyperlipidemia (defined as: 1.7 mmol/L ≤ TG \<4.5 mmol/L and 5.2 mmol/L ≤ TC \<6.2 mmol/L; or 1.7 mmol/L ≤ TG \<4.5 mmol/L and 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L; or 1.7 mmol/L ≤ TG \<4.5 mmol/L, 5.2 mmol/L ≤ TC \<6.2 mmol/L and 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L);

• Accompanied by overweight/obesity (24.0 ≤ BMI ≤40.0 kg/m²);

• Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;

• Have controlled of blood lipids solely through lifestyle interventions (diet and exercise) for at least 1 month prior to the screening period;

• People must possess communication and cognitive abilities to adhere to long-term medication, and fully understand the nature, significance, potential benefits, inconveniences, and risks of the study before participation;

• Fertile patients (male or female) must agree to use at least one medically approved contraceptive method (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the trial. Female with childbearing potential must have a negative blood pregnancy test during screening and must not be lactating;

• Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule

Locations
Other Locations
China
PKUCare Luzhong Hospital
RECRUITING
Zibo
Contact Information
Primary
Baojia Huang
huangbj@moonbio.com
+86-020-31603387
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Probiotic
Subjects receive AKM Lab-01 Enteric-coated Capsule
Placebo_comparator: Placebo
Subjects receive placebo
Related Therapeutic Areas
Sponsors
Leads: Moon (Guangzhou) Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov

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