RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.

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

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

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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