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

NCT04797442 | Unknown Phase 2

• 1 other identifier: WST001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obese; Overweight; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Body weight

  change of body weight from baseline

  12 weeks

• Fasting plasma glucose levels

  change of fasting plasma glucose from baseline

  12 weeks

Secondary Outcomes (30)

• Gut microbiome

  12 weeks

• Glycated haemoglobin (HbA1c)

  12 weeks

• 2-hour post-prandial plasma glucose levels

  12 weeks

• Fasting serum insulin levels

  12 weeks

• 2-hour post-prandial serum insulin levels

  12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Drug: WST01 strain product

Placebo comparator

PLACEBO COMPARATOR

Drug: placebo powder

Interventions

WST01 strain product DRUG

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)

Experimental

placebo powder DRUG

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)

Placebo comparator

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subjects with a history of taking hypoglycemic drugs;
• Subjects who are pregnant or in lactation;
• 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.);
• Subjects who were or are using oral hypoglycemic agents or insulin or incretin to control diabetes;
• 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);
• 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);
• Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 3 months;
• Subjects with a medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
• 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;
• Any condition that in the judgement of the investigator precludes participation.
• Details please see the study protocol.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 39879980 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PHD, MD

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 15, 2021
• Study Start: July 15, 2021
• Primary Completion: November 9, 2022
• Study Completion: March 31, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

CN (1)