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Not yet recruitingPhase NA

Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss

The Effect of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Medications for Weight Loss: a Randomized Double-blind Controlled Trial

Asset

GLP-1 / incretin class catch-all

Listed sites

5

Recruiting sites

-

Estimated enrollment

600

Study population

Chronic kidney disease, Obesity / overweight

Eligibility highlights

•BMI ≥28

Primary endpoint

•Concentrations of blood lipid levels in millimole

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07611552
Org study IDPrebiotics in GLP-1 RA users

Timeline

Milestones

Study first posted2026-05-28actual
Last update posted2026-06-03actual
Study start2026-06estimated (month precision)
Primary completion2026-11estimated (month precision)
Study completion2026-11estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Be overweight or obese (meeting any of the following criteria):

1. Obesity: BMI >=28 kg/m²;

2. Overweight (BMI >= 24 kg/m²) with at least one body weight-related comorbidity: obstructive sleep apnea syndrome, prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia, polycystic ovary syndrome, or non-alcoholic fatty liver disease.

•Must have received GLP-1 RA drugs (Semaglutide, Liraglutide, Benaglutide, Tirzepatide, or Mazdutide) for weight-loss intervention for at least 3 months, and plan to continue using them for the next six months.
•Age 18-64 years.
•Consent to participate and sign the informed consent form.

Exclusion criteria

•Currently using non-GLP-1 RA medications for weight-loss, or have undergone or plan to undergo weight-loss procedures within the next 4 months;
•Long-term user of prebiotics or probiotics (excluding fermented dairy products such as yogurt);
•Be allergic or intolerance to inulin-type substances;
•Have participated in in other clinical trials within the past 3 months or are currently participating in other clinical trials;
•Plan to be pregnant within the next year, are currently pregnant, or are breastfeeding;
•Deemed unsuitable for participation by the investigator's judgment.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
4
Cardiometabolic biomarkers
3
Weight & body composition
2
Glycemic / diabetes
2
Renal / kidney
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

change in body weight in kilograms (kg)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint

change in waist circumference in centimeters (cm)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint

change in level of insulin resistance

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL/min/1.73 m²)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

change in concentrations of blood lipid levels in millimole per liter (mmol/L).

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint

change in level of C-reactive protein (CRP) in milligram per liter (mg/L)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint

change in blood pressure in millimeters of mercury (mmHg)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

change in frequency of gastrointestinal symptoms

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

change in body fat percentage (%)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in level of gut microbiota abundance

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in level of gut microbiota diversity

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in concentrations of liver function markers in units per liter (U/L)

Time frame:From enrollment to the end of intervention at 4 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.