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ObesePhase 2NCT04797442

Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes

A Phase 2 study testing WST01 strain product in people with Obese and Overweight, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to conduct a randomized, double-blinded, placebo-controlled, multicenter clinical trial, evaluating the glucose-lowering and weight-loss effects of Akkermansia muciniphila WST01 strain in overweight or obese patients with Type 2 Diabetes. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obese, Overweight, Type 2 Diabetes
What is being tested?
WST01 strain product
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
15 Jul 2021to 31 Mar 2024
Phase
Phase 2
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Main Inclusion Criteria:

  1. Subjects with type 2 diabetes mellitus;
  2. Age 18-60 years;
  3. Overweight / obesity (24.0 ≤ BMI ≤ 40.0 kg/m2)；
  4. Subjects with or without other obesity related metabolic complications (hypertension, dyslipidemia, hyperuricemia, etc.);
  5. Subjects with screening HbA1c ≥ 7.0% and ≤ 10.0%, and the fasting blood glucose ≥ 7.0 mmol/l and ≤ 13.3 mmol/l；
  6. Subjects who are not taking any medications to control blood glucose;
  7. Subjects control blood glucose only by lifestyle intervention (diet and exercise) for at least 2 months before the screening period;
  8. Subjects understand the nature, significance, potential benefits, inconvenience, and risks of the study before it starts；
  9. Subjects fully understand the study produces and voluntarily sign the informed consent form.

Main Exclusion Criteria:

  1. Subjects with a history of taking hypoglycemic drugs;
  2. Subjects who are pregnant or in lactation;
  3. Subjects with type 1 diabetes, single gene mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
  4. Subjects who were or are using oral hypoglycemic agents or insulin or incretin to control diabetes;
  5. Subjects with liver and kidney dysfunction (alanine transaminase(ALT) / aspartate aminotransferase(AST)≥2.5×the upper limit of normal(ULN) set by the hospital, serum creatinine>1×ULN set by the hospital, or eGFR<60mL/min/1.73m2);
  6. Surgery with serious cardiovascular and cerebrovascular diseases (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, patients receiving interventional therapy, etc.) or stage III hypertension (systolic blood pressure cannot be controlled below 160 mmHg with three antihypertensive drugs);
  7. Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 3 months;
  8. Subjects with a medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
  9. Subjects with a medical history of intestine, or other digestive tract surgery (such as cholecystectomy) within one year, or other non-gastrointestinal surgery within 6 months;
  10. Any condition that in the judgement of the investigator precludes participation.

Details please see the study protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Effect of Akkermansia Muciniphila WST01 Strain in Patients With Type 2 Diabetes

The purpose of this study is to conduct a randomized, double-blinded, placebo-controlled, multicenter clinical trial, evaluating the glucose-lowering and weight-loss effects of Akkermansia muciniphila WST01 strain in overweight or obese patients with Type 2 Diabetes.

Read the detailed description

In the present study, about 60 overweight/obese and drug naïve type 2 diabetes patients will be enrolled from multiple centers in China. After screening, eligible subjects will be randomized (1:1) into two groups, taking either Akkermansia muciniphila WST01 strain product or placebo product for 12 weeks.

Blood, feces and urine samples will be collected before and after treatment. Metabolic parameters including waist and hip circumference, area of visceral and subcutaneous fat, glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), insulin, glucagon-like peptide 1 (GLP-1), inflammation factors and lipid levels will be measured. Furthermore, the change of gut microbiota and metabolites will be evaluated too.

The primary objective is to determine whether Akkermansia muciniphila WST01 strain has a positive effect in patients with Type 2 Diabetes. The secondary objective is to explore the effect of Akkermansia muciniphila WST01 strain on safety, intestinal flora, insulin sensitivity, and other metabolic indicators and metabolites in the patients.

Being tested
WST01 strain product, placebo powder
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WST01 strain productDrug

    orally given WST01 strain product, added onto lifestyle. The specific ingredients are the optimized Akkermansia muciniphila WST01 strain powder with maximum live bacteria of 5*10^10 CFU/g (1 g/pack, 3 packs QD, 20-30 min after breakfast)

  • placebo powderDrug

    orally given placebo powder (the specific ingrdients are the excipients of the WST01 strain powder), added onto lifestyle. (3 packs of placebo powder QD, 20-30 min after breakfast)

Study groups in NCT04797442
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Drug: WST01 strain product
Placebo comparatorPlacebo comparatorNot described
Receives: Drug: placebo powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    change of body weight from baseline

    Measured: 12 weeks

  2. Fasting plasma glucose levels

    change of fasting plasma glucose from baseline

    Measured: 12 weeks

Secondary outcomes (30)

  1. Gut microbiome

    including fecal intestinal flora metagenome

    Measured: 12 weeks

  2. Glycated haemoglobin (HbA1c)

    Measured: 12 weeks

  3. 2-hour post-prandial plasma glucose levels

    Measured: 12 weeks

  4. Fasting serum insulin levels

    Measured: 12 weeks

  5. 2-hour post-prandial serum insulin levels

    Measured: 12 weeks

  6. Fasting glucagon-like peptide-1 (GLP-1) levels

    Measured: 12 weeks

  7. 2-hour post-prandial GLP-1 levels

    Measured: 12 weeks

  8. Serum triglycerides

    Measured: 12 weeks

  9. Serum total cholesterol

    Measured: 12 weeks

  10. Serum LDL-c

    Measured: 12 weeks

  11. Serum HDL-c

    Measured: 12 weeks

  12. Area of visceral and subcutaneous fat

    Measured: 12 weeks

  13. Waist and hip circumference

    Measured: 12 weeks

  14. Energy expenditure

    using metabolic chamber to measure energy expenditure

    Measured: 12 weeks

  15. Blood metabolomics profile measurement

    In aid of LC/MS and GC/MS technique, etc, we will measure the metabolomics molecular profile in blood samples before and after treatment. The metabolomics measurement will help to detect the profile of all kinds of bile acid species, lipids species and amino acid species, etc. The composition change of all these biological molecular induced by the treatment is our major interest rather than single molecular quantification.

    Measured: 12 weeks

  16. Inflammation markers

    including hs-CRP, TNF-alfa, IL-6, and IL-8, etc

    Measured: 12 weeks

  17. Systolic and diastolic blood pressure

    Safety outcomes

    Measured: 12 weeks

  18. Body temperature

    Safety outcomes

    Measured: 12 weeks

  19. Pulse rate

    Safety outcomes

    Measured: 12 weeks

  20. White blood cell (WBC) count

    Safety outcomes

    Measured: 12 weeks

  21. Red blood cell (RBC) count

    Safety outcomes

    Measured: 12 weeks

  22. Hemoglobin levels

    Safety outcomes

    Measured: 12 weeks

  23. Platelet count

    Safety outcomes

    Measured: 12 weeks

  24. Hepatic function

    including alanine aminotransferase, aspartate aminotransferase，ɣ-glutamyltransferase, and alkaline phosphatase

    Measured: 12 weeks

  25. Renal function

    including serum urea nitrogen, serum creatinine, and serum urinary acid

    Measured: 12 weeks

  26. Adverse events

    Safety outcomes

    Measured: 12 weeks

  27. Fasting serum C peptide levels

    Measured: 12 weeks

  28. 2-hour post-prandial serum C peptide levels

    Measured: 12 weeks

  29. Lean mass

    using DEXA scan to measure lean mass

    Measured: 12 weeks

  30. Fat mass

    using DEXA scan to measure fat mass

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start15 Jul 2021
  3. Primary completion9 Nov 2022
  4. Study completion31 Mar 2024 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797442
Sponsor's protocol ID
WST001
Status last verified
Oct 2023
First submitted
3 Mar 2021
Last updated
17 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Liu R, Chen Y, Cao Z, Liu C, Bao R, Wang Y, Huang S, Pan S, Qin L, Wang J, Ning G, Wang W. Akkermansia muciniphila supplementation in patients with overweight/obese type 2 diabetes: Efficacy depends on its baseline levels in the gut. Cell Metab. 2025 Mar 4;37(3):592-605.e6. doi: 10.1016/j.cmet.2024.12.010. Epub 2025 Jan 28.

    PubMed 39879980

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing WST01 strain product in people with Obese and Overweight, run by Shanghai Jiao Tong University School of Medicine 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?

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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Body weight (time frame: 12 weeks). 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?

On the ClinicalTrials.gov record for NCT04797442, which also lists 1 linked publication.

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 17 Oct 2023.

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