- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07301437
RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.
March 20, 2026 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
A Real-world Study of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.
To evaluate the differences in weight loss between liraglutide monotherapy and combined with orlistat in overweight/obese patients.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- BMI: ≤ 35 kg/m² and ≥ 30 kg/m², or ≥ 27 kg/m² and having at least one obesity-related complication (such as hypertension, type 2 diabetes, dyslipidemia)
- Voluntarily sign the informed consent form, agreeing to cooperate in completing the 24-week treatment and follow-up.
- No severe cognitive impairment or mental illness, and able to understand and comply with the research requirements.
Exclusion Criteria:
- Allergy to liraglutide, orlistat or excipients
- Severe liver and kidney dysfunction: ALT or AST> three times the upper limit of normal, or eGFR <30 mL/min
- Thyroid diseases: Personal or family history of medullary thyroid cancer, or uncontrolled hyperthyroidism/hypothyroidism
- Gastrointestinal diseases: Having gastrointestinal surgery within 3 months, or inflammatory bowel disease or active gastric and duodenal ulcers
- Pregnant or lactating women
- Others: Type 1 diabetes, malignant tumors, severe cardiovascular diseases (such as NYHA IV).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
combination therapy
|
|
Active Comparator: control group
|
liraglutide monotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weight loss
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Study Registration Dates
First Submitted
December 11, 2025
First Submitted That Met QC Criteria
December 23, 2025
First Posted (Actual)
December 24, 2025
Study Record Updates
Last Update Posted (Actual)
March 23, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2025-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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