NCT07847515Not 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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- 1 Feb 2027
- Primary completion date
- Jun 2027
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Obesity
- NCT number
- NCT07847515
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Feb 2027 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gastrointestinal surgery within 6 months
Other illness
- Known inflammatory bowel disease (IBD), intestinal obstruction, or severe gastrointestinal disease
- History of malignancy
- Severe psychiatric or cognitive disorder
- Acute infection within 1 month
- Any condition deemed unsuitable by the investigator
Lab values
- Severe hepatic or renal impairment (ALT/AST \> 3x ULN, eGFR \< 30 ml/min/1.73m2)
Other
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.