28≤BMI≤35Kg/m2NCT06780007
Weight Loss Effect of Akkermansia Muciniphila in Obese Patients
A study testing Probiotic in people with 28≤BMI≤35Kg/m2, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 28≤BMI≤35Kg/m2
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2025to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- 1) Age 18-65 years old; 2）28≤BMI≤35Kg/m2； 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss
Who cannot join
- Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
- Oral antibiotics in the past 1 month prior to enrollment;
- No use of probiotic prebiotic products before 3 weeks of intervention;
- people without a fitness fat loss program or history of gastric surgery during the intervention period;
- Patients with severe gastrointestinal diseases;
- Those who are known to be allergic to synbiotics or similar products;
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- Patients with no self-awareness and those with mental abnormalities;
- Have a history of organ transplantation or malignant tumor disease;
- Concurrent use of other experimental drugs or in other clinical trials;
- Have a history of alcohol, tobacco and other drug abuse;
- Those who are expected to be unable to complete the magnetic resonance examination;
- Combined with serious medical diseases or conditions: such as clinically serious (i.e., active) cardiac disease, severe, uncontrolled medical diseases and infections, severe uncontrollable digestive disorders, severe electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, pulmonary, hepatic, renal failure, peripheral neuropathy symptoms, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, the Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.
This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.
- Conditions
- 28≤BMI≤35Kg/m2
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).
PlaceboDietary supplement
The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | 10B AFU/four capsules/day Akk11, before meals; Storage: store in a cool, dry place without sun exposure. Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Four maltodextrin capsules/day, before meals; Storage: store in a cool, dry place without sun exposure. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index(BMI)
BMI = Weight (kg) / [Height (m)]². 24kg/m² ≤ BMI < 28 kg/m² is in the overweight range, and BMI ≥ 28 kg/m² is in the obesity range.
Measured: Day 0, week4, week8, week12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start21 Jan 2025
- Primary completion28 Feb 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 28≤BMI≤35Kg/m2Studies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiangpeng Wei, Doctor, Principal investigator, The First Affiliated Hospital, the Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780007
- Sponsor's protocol ID
- WK2025003
- Status last verified
- Aug 2025
- First submitted
- 14 Jan 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT06780007
- Acronym / sponsor ID
- WK2025003
- Conditions
- 28≤BMI≤35Kg/m2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 17 Jan 2025 (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 intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic10B AFU/four capsules/day Akk11, before meals; Storage: store in a cool, dry place without sun exposure. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboFour maltodextrin capsules/day, before meals; Storage: store in a cool, dry place without sun exposure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -
- 1) Age 18-65 years old; 2）28≤BMI≤35Kg/m2； 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss
Key exclusion criteria (12 listed)
- Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
- Oral antibiotics in the past 1 month prior to enrollment;
- No use of probiotic prebiotic products before 3 weeks of intervention;
- people without a fitness fat loss program or history of gastric surgery during the intervention period;
- Patients with severe gastrointestinal diseases;
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 |
|---|---|---|
| ProbioticThe trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12). | Dietary supplement | Probiotic group |
| PlaceboThe trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12). | Dietary supplement | Placebo group |
Primary outcome
Change in Body Mass Index(BMI)
Time frame: Day 0, week4, week8, week12.
BMI = Weight (kg) / [Height (m)]². 24kg/m² ≤ BMI < 28 kg/m² is in the overweight range, and BMI ≥ 28 kg/m² is in the obesity range.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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. This study is not recruiting at the moment.
Jiangpeng Wei, Doctor principal investigator
The First Affiliated Hospital, the Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with 28≤BMI≤35Kg/m2, run by Wecare Probiotics 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 3 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index(BMI) (time frame: Day 0, week4, week8, week12.). 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 3 Sep 2025.