Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
Key facts
- Where
- Nanjing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07847515, who can take part
Where in China
- Nanjing First HospitalNanjing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanjing First Hospital, Nanjing Medical University
- Trial code
- NCT07847515
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
Effects of Tirzepatide on Gut Microbiota and the Recovery Pattern of Gastric Emptying After Drug Withdrawal in Obese Patients
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.
Inclusion: 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: Gastrointestinal surgery within 6 months; 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; Severe hepatic or renal impairment (ALT/AST > 3x ULN, eGFR < 30 ml/min/1.73m2); Pregnancy or lactation.