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

NCT07847515 · tracked via the Priya Life Science China tracker

Sponsor

Nanjing First Hospital, Nanjing Medical University

Phase

Observational

Started

2027-02-01

Last updated

2026-10-15

Condition(s) studied

Obesity / Overweight

Investigational drug(s) / intervention(s)

Tirzepatide →

Tirzepatide: Tirzepatide is administered as part of routine clinical care, not assigned by the investigator.

Study summary

This is an observational cohort study. The primary objective is to analyze the dynamic changes in gut microbiota and metabolic profiles in obese patients treated with Tirzepatide. A total of 80 participants will be enrolled: 40 normal-weight controls (NW group) and 40 obese patients receiving Tirzepatide as part of their routine clinical care (OB-T group). Fecal samples for 16S rRNA sequencing and blood samples for metabolic markers will be collected at baseline and after 3 months. Changes in gut microbiota diversity and composition will be correlated with improvements in glucose and lipid metabolism. As per the approved protocol, exploratory follow-up assessments of gastrointestinal symptoms and gastric emptying parameters will also be conducted post-treatment.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Changes in Gut Microbiota Characteristics — Baseline (0 week) and 3 months
Assessed by 16S rRNA V3-V4 region sequencing. Includes Alpha diversity (Shannon, Simpson, Chao1), Beta diversity (PCoA), and core differential genera abundance (e.g., Akkermansia, Bacteroides).

Trial sites (1)

Facility	City	Region	Status
Nanjing First Hospital	Nanjing	Jiangsu

On this site

📄 Mounjaro (tirzepatide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07847515 on ClinicalTrials.gov ↗ ← All trials in China