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

NCT ID: NCT07301437

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-08-31

Brief Summary

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To evaluate the differences in weight loss between liraglutide monotherapy and combined with orlistat in overweight/obese patients.

Detailed Description

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Conditions

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Overweight and Obese Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Group Type EXPERIMENTAL

liraglutide combined with orlistat

Intervention Type DRUG

combination therapy

control group

Group Type ACTIVE_COMPARATOR

liraglutide monotherapy

Intervention Type DRUG

liraglutide monotherapy

Interventions

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liraglutide monotherapy

liraglutide monotherapy

Intervention Type DRUG

liraglutide combined with orlistat

combination therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- 1.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) 2.Voluntarily sign the informed consent form, agreeing to cooperate in completing the 24-week treatment and follow-up.

3.No severe cognitive impairment or mental illness, and able to understand and comply with the research requirements.

Exclusion Criteria

* 1\. Allergy to liraglutide, orlistat or excipients 2.Severe liver and kidney dysfunction: ALT or AST\> three times the upper limit of normal, or eGFR \<30 mL/min 3.Thyroid diseases: Personal or family history of medullary thyroid cancer, or uncontrolled hyperthyroidism/hypothyroidism 4.Gastrointestinal diseases: Having gastrointestinal surgery within 3 months, or inflammatory bowel disease or active gastric and duodenal ulcers 5.Pregnant or lactating women 6.Others: Type 1 diabetes, malignant tumors, severe cardiovascular diseases (such as NYHA IV).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KY-2025-202

Identifier Type: -

Identifier Source: org_study_id