Mechanistic study of orlistat in ameliorating overweight/obesity through modulation of gut microbiota

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600129223

Enrollment

Unknown

Registered

2026-08-01

Start date

2024-09-04

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Interventions

Intervention group:Orlistat 120 mg administered three times daily for 12 weeks, combined with a low-calorie diet (1200-1500 kcal/day) and at least 150 minutes of physical activity per week throughout

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years and =24 kg/m^2. 3. Able to comply with dietary and exercise guidance and provide signed informed consent. 4. Women of childbearing potential agree to adopt effective contraceptive measures during the treatment period.

Exclusion criteria

Exclusion criteria: 1. Patients with malignant tumors or active tuberculosis. 2. History of acute or chronic gastrointestinal diseases or gastrointestinal surgery. 3. Long-term use of acid-suppressing medications or non-steroidal anti-inflammatory drugs (NSAIDs). 4. Use of antibiotics within one month prior to enrollment or anticipated use during the study period. 5. Use of prebiotics, probiotics, or live bacterial preparations within one week prior to sample collection. 6. Use of any of the following medications within three months prior to enrollment: phentermine-topiramate, naltrexone-bupropion, metformin, GLP-1 receptor agonists, SGLT2 inhibitors, other hypoglycemic agents, statins, beta-blockers, beta-agonists, ACE inhibitors, corticosteroids, proton pump inhibitors (PPIs), laxatives, selective serotonin reuptake inhibitor (SSRI) antidepressants, acetaminophen, or other drugs that may influence study endpoints. 7. Poor compliance with the study protocol.

Design outcomes

Primary

Measure	Time frame
Percentage change in body weight after 12 weeks of orlistat intervention;	—

Secondary

Measure	Time frame
Body weight;Waist circumference;Hip circumference;Fasting blood glucose;Fasting insulin;Blood lipids;Uric acid;Liver enzymes;Body composition;Gut microbiota;Blood pressure;	—

Countries

China

Contacts

Public ContactZhang Haohao

The First Affiliated Hospital of Zhengzhou University

fcczhanghh@zzu.edu.cn+86 138 3810 0727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026