NCT07898267|Not Yet Recruiting
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Sponsor study identifier
interventional
150
1 country
1
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overweight and obesity are common metabolic disorders associated with increased risks of diabetes, cardiovascular disease, and other health problems. The gut microbiota plays an important role in regulating metabolism, inflammation, and intestinal health. Akkermansia, a beneficial gut bacterium, has been associated with metabolic health and may have potential benefits for weight management. This study aims to investigate the relationship between gut microbiota characteristics and overweight or obesity and to evaluate the efficacy and safety of Akkermansia supplementation in individuals with overweight or obesity. The study consists of two stages. The first stage is an observational study comparing gut microbiota characteristics between healthy individuals and individuals with overweight or obesity. The second stage is a randomized, double-blind, placebo-controlled clinical trial in which eligible participants with overweight or obesity will receive either Akkermansia supplementation or placebo once daily for 12 weeks, followed by follow-up through Week 24. The study will evaluate changes in body weight, metabolic health, gut microbiota characteristics, related metabolites, and safety outcomes. The findings may provide clinical evidence regarding the potential use of Akkermansia supplementation for the management of overweight and obesity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2026
Actual (reported)October 27, 2026
Actual (reported)January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage Change in Body Weight from Baseline at Week 12
Percentage change in body weight from baseline to Week 12, calculated as \[(body weight at Week 12 - body weight at baseline) / body weight at baseline\] × 100. The percentage change will be compared between the Akkermansia supplementation group and the placebo group.
Baseline and Week 12
Change in Body Mass Index from Baseline
Baseline, Weeks 4, 8, 12, 18, and 24.
Change in Waist Circumference from Baseline
Baseline, Weeks 4, 8, 12, 18, and 24.
Change in Body Fat Percentage from Baseline
Baseline, Weeks 12 and 24.
Change in Fasting Blood Glucose from Baseline
Baseline, Weeks 12 and 24.
Change in Glycated Hemoglobin from Baseline
Baseline, Weeks 12 and 24.
Exploratory Analysis of Baseline Akkermansia Characteristics and Treatment Response
Baseline to Week 24
Correlation Analysis Between Gut Microbiota, Metabolites and Clinical Parameters
Baseline, Week 12, and Week 24
Participants with overweight or obesity will receive oral Akkermansia supplementation once daily for 12 weeks. The intervention aims to evaluate the effects of Akkermansia supplementation on body weight, metabolic parameters, gut microbiota characteristics, related metabolites, and safety outcomes. Participants will be followed through Week 24 to assess treatment effects and safety.
Participants with overweight or obesity will receive a placebo once daily for 12 weeks. The placebo will have an appearance, color, odor, packaging, and administration method identical to those of the Akkermansia supplement. Participants will be followed through Week 24 to assess treatment effects and safety.
Akkermansia supplementation will be administered orally once daily for 12 weeks to participants with overweight or obesity. All participants will receive standardized lifestyle guidance throughout the intervention period. Treatment effects and safety will be assessed through Week 24.
The placebo will be administered orally once daily for 12 weeks to participants with overweight or obesity. It will be identical to the Akkermansia supplement in appearance, color, odor, packaging, and administration method. All participants will receive standardized lifestyle guidance throughout the intervention period. Treatment effects and safety will be assessed through Week 24.
No. 1, Minde Road, Donghu District, Nanchang University Second Affiliated Hospital
Nanchang, Jiangxi, 330000, China
First Submitted
October 14, 2026
First Posted
October 27, 2026
Study Start
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
Contact the study team to confirm eligibility.
September 1, 2028
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
Individual participant data will not be shared with other researchers. The study data will be used for the purposes specified in the protocol and analyzed by the study investigators.
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Source: ClinicalTrials.gov.
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