Obesity / OverweightNCT07847515
Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
An observational study of Obesity / Overweight, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity / Overweight
- What is being tested?
- Tirzepatide
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2027to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing First Hospital
Nanjing, Jiangsu
ZongDan Jiang, +86-17590011635, alia_01@sina.com
About this study
Official title: 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.
Read the detailed description
Obesity is a global public health crisis, and gut microbiota dysbiosis plays a crucial role in its pathophysiology. Tirzepatide, a dual GIP/GLP-1 receptor agonist, has shown significant weight loss effects, but its impact on the human gut microbiome remains largely unexplored. This observational study aims to fill this gap by characterizing the longitudinal changes in gut microbiota in obese patients undergoing routine Tirzepatide treatment. The investigators will use 16S rRNA V3-V4 region sequencing to analyze microbial diversity and composition (Shannon, Simpson, Chao1 indices, PCoA, LEfSe). Furthermore, The investigators will explore the associations between these microbial shifts and improvements in glucose and lipid metabolism . As secondary and exploratory objectives, gastrointestinal symptoms (GSRS) and gastric emptying function (measured by 13C-octanoic acid breath test) will be monitored during the treatment and withdrawal phases to better understand the overall physiological impact of the treatment.
- Conditions
- Obesity / Overweight
- Being tested
- Tirzepatide
- Keywords
- Tirzepatide, Gut Microbiota, Obesity, Metabolic Improvement
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzepatide is administered as part of routine clinical care, not assigned by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight Control (NW) | Healthy volunteers with normal weight. No intervention is administered. Blood and fecal samples are collected. | |
| Obese Treatment (OB-T) | Obese patients receiving Tirzepatide as part of their routine clinical care. The investigator only observes and collects blood and fecal samples. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gut Microbiota Characteristics
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).
Measured: Baseline (0 week) and 3 months
Secondary outcomes (3)
Changes in Fasting Plasma Glucose,, Lipid Profile, and Body Weight
Assessed by routine fasting blood tests and anthropometric measurements. Metabolic markers include fasting plasma glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and body weight.
Measured: Baseline (0 week) and 3 months
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦
Assessed via the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.
Measured: Baseline (0 week) and 3 months
Change in Gastric Emptying Function
Measured by 13C-octanoic acid breath test.
Measured: Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Feb 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity / OverweightStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZongDan Jiang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847515
- Sponsor's protocol ID
- KY20260430-05-KS-01
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to participant privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tirzepatide on Gut Microbiota and the Recovery Pattern of Gastric Emptying After Drug Withdrawal in Obese Patients
- ClinicalTrials.gov ID
- NCT07847515
- Acronym / sponsor ID
- KY20260430-05-KS-01
- Conditions
- Obesity / Overweight
- Keywords
- Tirzepatide, Gut Microbiota, Obesity, Metabolic Improvement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a global public health crisis, and gut microbiota dysbiosis plays a crucial role in its pathophysiology. Tirzepatide, a dual GIP/GLP-1 receptor agonist, has shown significant weight loss effects, but its impact on the human gut microbiome remains largely unexplored. This observational study aims to fill this gap by characterizing the longitudinal changes in gut microbiota in obese patients undergoing routine Tirzepatide treatment. The investigators will use 16S rRNA V3-V4 region sequencing to analyze microbial diversity and composition (Shannon, Simpson, Chao1 indices, PCoA, LEfSe). Furthermore, The investigators will explore the associations between these microbial shifts and improvements in glucose and lipid metabolism . As secondary and exploratory objectives, gastrointestinal symptoms (GSRS) and gastric emptying function (measured by 13C-octanoic acid breath test) will be monitored during the treatment and withdrawal phases to better understand the overall physiological impact of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Weight Control (NW) | – | –Healthy volunteers with normal weight. No intervention is administered. Blood and fecal samples are collected. |
| Obese Treatment (OB-T) | – | Drug: TirzepatideObese patients receiving Tirzepatide as part of their routine clinical care. The investigator only observes and collects blood and fecal samples. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideTirzepatide is administered as part of routine clinical care, not assigned by the investigator. | Drug | Obese Treatment (OB-T) |
Primary outcome
Changes in Gut Microbiota Characteristics
Time frame: 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).
3 secondary outcomes
Changes in Fasting Plasma Glucose,, Lipid Profile, and Body Weight
Time frame: Baseline (0 week) and 3 months
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦
Time frame: Baseline (0 week) and 3 months
Change in Gastric Emptying Function
Time frame: Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Data will not be shared due to participant privacy and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity / Overweight, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZongDan Jiang (17590011635, alia_01@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gut Microbiota Characteristics (time frame: Baseline (0 week) and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.