Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity

NCT07331974 | Not Yet Recruiting

• 1 other identifier: MN-AKM-102
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.

Conditions

Overweight , Obesity

Keywords

Akkermansia Muciniphila; Obesity; Overweight; Probiotics

Outcome Measures

Primary Outcomes (2)

• Changes in BMI

  Changes in BMI from baseline will be assessed

  Baseline, Day 30, Day 60, Day 90

• Changes in body weight

  Changes in body weight from baseline will be assessed.

  Baseline, Day 30, Day 60, Day 90

Secondary Outcomes (5)

• Changes in TC

  Baseline, Day 90

• Changes in HbA1c

  Baseline, Day 30, Day 90

• Changes in Uric Acid

  Baseline, Day30, Day90

• Changes in Blood Pressure

  Baseline, Day 30, Day 60, Day 90

• Changes in LDL-C

  Baseline, Day 90

Study Arms (2)

Probiotics

EXPERIMENTAL

Subjects receive investigational product AKM Lab-01

Drug: AKM Lab-01

Placebo

PLACEBO COMPARATOR

Participants receive placebo

Drug: Placebo

Interventions

AKM Lab-01 DRUG

A specific dose of AKM Lab-01 will be administered orally once daily for a period of 3 months.

Probiotics

Placebo DRUG

Placebo will be administered orally once daily for a period of 3 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Age: 18-60 years old (inclusive); Gender: male or female.
• \) Body Mass Index (24.0≤BMI≤40.0 kg/m²).
• \) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month.
• \) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening.
• \) Processes adequate communication and cognitive abilities, is expected to be compliant with long-term medication, and has understood the nature, significance, potential benefits, inconveniences, and risks of the study prior to enrollment.
• \) For participants of childbearing potential (male or female): Must agree to use at least one medically approved form of contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative serum pregnancy test at screening and must be non-lactating.
• \) Voluntarily agrees to participate by signing the inform consent form and commits to follow the trial treatment plan and visit schedule.

You may not qualify if:

• \) A clear history of neurological or psychiatric disorders (including epilepsy and dementia).
• \) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure.
• \) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease.
• \) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness.
• \) Participants with a family history of genetically inherited metabolic disorders.
• \) Participants currently taking hepatotropic medications.
• \) Participants with a history of prior bariatric surgery.
• \) Presence of poorly controlled or unstable acute/chronic diseases, including but not limited to:
• Cardiovascular diseases: Unstable angina, myocardial infarction within the past 6 months, symptomatic congestive heart failure (NYHA Class Ⅱ or higher), severe arrhythmia, ect.
• Uncontrolled active infectious diseases, malignancies, ect.
• \) Participants with hepatic or renal insufficiency, defined as:
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 2.5 × ULN (Upper Limit of Normal);
• Serum total bilirubin \> 2.5 × ULN;
• Creatinine (Cr) \> 1.5 × ULN.
• \) Urine amylase ≥ 1.5 × ULN, or any other laboratory abnormality deemed by the investigator to be clinically significant and incompatible with study participation.

Sponsors & Collaborators

• Moon (Guangzhou) Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangzhou Huangpu District People Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Baojia Huang

CONTACT

+86-15588105007; huangbj@moonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)