Overweight , ObesityNCT07331974
Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity
A study testing AKM Lab-01 in people with Overweight , Obesity, run by Moon (Guangzhou) Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- AKM Lab-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) Age: 18-60 years old (inclusive); Gender: male or female.
- 2) Body Mass Index (24.0≤BMI≤40.0 kg/m²).
- 3) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month.
- 4) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening.
- 5) 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.
- 6) 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.
- 7) Voluntarily agrees to participate by signing the inform consent form and commits to follow the trial treatment plan and visit schedule.
Who cannot join
- 1) A clear history of neurological or psychiatric disorders (including epilepsy and dementia).
- 2) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure.
- 3) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease.
- 4) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness.
- 5) Participants with a family history of genetically inherited metabolic disorders.
- 6) Participants currently taking hepatotropic medications.
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- 7) Participants with a history of prior bariatric surgery.
- 8) 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.
- 9) 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.
- 10) Urine amylase ≥ 1.5 × ULN, or any other laboratory abnormality deemed by the investigator to be clinically significant and incompatible with study participation.
- 11) History of acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) within the past 3 months.
- 12) History of gastrointestinal surgery within the past year, or the presence of severe, active gastrointestinal disease that is not stabilized and may affect drug absorption, distribution, metabolism, or excretion.
- 13) Know hypersensitivity or allergy to any active ingredient or excipient of the investigational product.
- 14) Use of antibiotic therapy or intake of probiotics/prebiotic supplements within 3 month prior to screening.
- 15) Excessive alcohol consumption (defined as > 30 grams per day for men or > 20 gram, sraems) with the past 10 years.
- 16) pregnant or lactating women.
- 17) Any other medical condition that, in the judgement of the investigator, may put the participant at increased or be aggravated by participation in the study. The specific reason for exclusion based on this criterion must be documented.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Huangpu District People's Hospital
Guangzhou, Guangdong
IRB of Guangzhou Huangpu District People's Hospital, 86-020-82087088-50113, gzkfqyyyxllwyh@hp.qov.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Access the Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 in Participents With Overweigh and Obesity
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
- Being tested
- AKM Lab-01, Placebo
- Keywords
- Akkermansia Muciniphila, Obesity, Overweight, Probiotics
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKM Lab-01Drug
A specific dose of AKM Lab-01 will be administered orally once daily for a period of 3 months.
PlaceboDrug
Placebo will be administered orally once daily for a period of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Subjects receive investigational product AKM Lab-01 Receives: Drug: AKM Lab-01 |
| Placebo | Placebo comparator | Participants receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BMI
Changes in BMI from baseline will be assessed
Measured: Baseline, Day 30, Day 60, Day 90
Changes in body weight
Changes in body weight from baseline will be assessed.
Measured: Baseline, Day 30, Day 60, Day 90
Secondary outcomes (5)
Changes in TC
Changes in serum TC from baseline will be assessed.
Measured: Baseline, Day 90
Changes in HbA1c
Changes in HbA1c from baseline will be assessed.
Measured: Baseline, Day 30, Day 90
Changes in Uric Acid
Changes in Uric Acid from baseline will be assessed.
Measured: Baseline, Day30, Day90
Changes in Blood Pressure
Changes of systolic and diastolic blood pressure from baseline will be assessed.
Measured: Baseline, Day 30, Day 60, Day 90
Changes in LDL-C
Changes in serum LDL-C from baseline will be assessed.
Measured: Baseline, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start18 Jun 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331974
- Sponsor's protocol ID
- MN-AKM-102
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Access the Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 in Participents With Overweigh and Obesity
- ClinicalTrials.gov ID
- NCT07331974
- Acronym / sponsor ID
- MN-AKM-102
- Conditions
- Overweight , Obesity
- Keywords
- Akkermansia Muciniphila, Obesity, Overweight, Probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Drug: AKM Lab-01Subjects receive investigational product AKM Lab-01 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1) Age: 18-60 years old (inclusive); Gender: male or female.
- 2) Body Mass Index (24.0≤BMI≤40.0 kg/m²).
- 3) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month.
- 4) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening.
- 5) 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.
Key exclusion criteria (22 listed)
- 1) A clear history of neurological or psychiatric disorders (including epilepsy and dementia).
- 2) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure.
- 3) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease.
- 4) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness.
- 5) Participants with a family history of genetically inherited metabolic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKM Lab-01A specific dose of AKM Lab-01 will be administered orally once daily for a period of 3 months. | Drug | Probiotics |
| PlaceboPlacebo will be administered orally once daily for a period of 3 months. | Drug | Placebo |
Primary outcome
Changes in BMI
Time frame: Baseline, Day 30, Day 60, Day 90
Changes in BMI from baseline will be assessed
Changes in body weight
Time frame: Baseline, Day 30, Day 60, Day 90
Changes in body weight from baseline will be assessed.
5 secondary outcomes
Changes in TC
Time frame: Baseline, Day 90
Changes in HbA1c
Time frame: Baseline, Day 30, Day 90
Changes in Uric Acid
Time frame: Baseline, Day30, Day90
Changes in Blood Pressure
Time frame: Baseline, Day 30, Day 60, Day 90
Changes in LDL-C
Time frame: Baseline, Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKM Lab-01 in people with Overweight , Obesity, run by Moon (Guangzhou) Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baojia Huang (86-020-31603387, huangbj@moonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BMI (time frame: Baseline, Day 30, Day 60, Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.