Not yet recruiting

Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients

Effects of Tirzepatide on Gut Microbiota and the Recovery Pattern of Gastric Emptying After Drug Withdrawal in Obese Patients

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≤24

Primary endpoint

•Changes in Gut Microbiota Characteristics

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 IDNCT07847515

Org study IDKY20260430-05-KS-01

Timeline

Milestones

Study first posted2026-09-29actual

Last update posted2026-10-15actual

Study start2027-02-01estimated

Study completion2027-07-01estimated

Primary completion2027-06estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Sampling methodNon probability sample

Study population text

A total of 80 participants will be enrolled at Nanjing First Hospital, including 40 normal-weight healthy controls and 40 obese patients receiving routine Tirzepatide treatment.

Inclusion criteria

Normal Weight Control Group:

•Age 18-65 years

•18.5 <= BMI < 24 kg/m2

•No obesity-related complications

•No diabetes, hypertension, or other metabolic diseases

•No antibiotics, probiotics, or prebiotics in the past 3 months

Obese Treatment Group:

•Age 18-65 years

•BMI >= 30 kg/m2, or BMI >= 27 kg/m2 with at least one obesity-related complication

•Physician-assessed indication for Tirzepatide

•Planned initiation of Tirzepatide as part of routine clinical care

•No antibiotics, probiotics, or prebiotics in the past 3 months

Exclusion criteria

•Known inflammatory bowel disease (IBD), intestinal obstruction, or severe gastrointestinal disease

•Gastrointestinal surgery within 6 months

•Severe hepatic or renal impairment (ALT/AST > 3x ULN, eGFR < 30 ml/min/1.73m2)

•History of malignancy

•Severe psychiatric or cognitive disorder

•Pregnancy or lactation

•Acute infection within 1 month

•Any condition deemed unsuitable by the investigator

Endpoints (4)

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)

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Changes in Fasting Plasma Glucose,, Lipid Profile, and Body Weight

Time frame:Baseline (0 week) and 3 months

concentration, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦

Time frame:Baseline (0 week) and 3 months

change from baseline, event

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Changes in Gut Microbiota Characteristics

Time frame:Baseline (0 week) and 3 months

descriptive

Secondary/protocol endpoint/low confidence

Change in Gastric Emptying Function

Time frame:Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.