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Status unknownNCT04797442Updated Oct 17, 2023

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

A Phase 2 interventional study of WST01 strain product and placebo powder in Obese, Overweight and Type 2 Diabetes, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obese
  • Overweight
  • Type 2 Diabetes
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 60 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 370 studies on the registry; 107 are open to participants now.

Browse Shanghai Jiao Tong University School of Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental

    Drug: WST01 strain product

  • Placebo comparator
    Placebo comparator

    Drug: placebo powder

Interventions

  • DrugWST01 strain product

    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)

  • Drugplacebo powder

    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)

06

What researchers measure

Primary outcomes

  1. Body weight

    change of body weight from baseline

    Time frame: 12 weeks

  2. Fasting plasma glucose levels

    change of fasting plasma glucose from baseline

    Time frame: 12 weeks

Secondary outcomes

  1. Gut microbiome

    including fecal intestinal flora metagenome

    Time frame: 12 weeks

  2. Glycated haemoglobin (HbA1c)

    Time frame: 12 weeks

  3. 2-hour post-prandial plasma glucose levels

    Time frame: 12 weeks

  4. Fasting serum insulin levels

    Time frame: 12 weeks

  5. 2-hour post-prandial serum insulin levels

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  8. Serum triglycerides

    Time frame: 12 weeks

  9. Serum total cholesterol

    Time frame: 12 weeks

  10. Serum LDL-c

    Time frame: 12 weeks

  11. Serum HDL-c

    Time frame: 12 weeks

  12. Area of visceral and subcutaneous fat

    Time frame: 12 weeks

  13. Waist and hip circumference

    Time frame: 12 weeks

  14. Energy expenditure

    using metabolic chamber to measure energy expenditure

    Time frame: 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.

    Time frame: 12 weeks

  16. Inflammation markers

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

    Time frame: 12 weeks

  17. Systolic and diastolic blood pressure

    Safety outcomes

    Time frame: 12 weeks

  18. Body temperature

    Safety outcomes

    Time frame: 12 weeks

  19. Pulse rate

    Safety outcomes

    Time frame: 12 weeks

  20. White blood cell (WBC) count

    Safety outcomes

    Time frame: 12 weeks

  21. Red blood cell (RBC) count

    Safety outcomes

    Time frame: 12 weeks

  22. Hemoglobin levels

    Safety outcomes

    Time frame: 12 weeks

  23. Platelet count

    Safety outcomes

    Time frame: 12 weeks

  24. Hepatic function

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

    Time frame: 12 weeks

  25. Renal function

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

    Time frame: 12 weeks

  26. Adverse events

    Safety outcomes

    Time frame: 12 weeks

  27. Fasting serum C peptide levels

    Time frame: 12 weeks

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

    Time frame: 12 weeks

  29. Lean mass

    using DEXA scan to measure lean mass

    Time frame: 12 weeks

  30. Fat mass

    using DEXA scan to measure fat mass

    Time frame: 12 weeks

07

Study locations

1 site
  • Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine
    Shanghai, Shanghai Municipality 200025, China
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04797442
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Wang Weiqing (Professor, PHD, MD, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Mar 15, 2021
Start date
Jul 15, 2021
Primary completion
Nov 9, 2022
Completion
Mar 31, 2024 (estimated)
Last update
Oct 17, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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