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

T

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status and phase

Not yet enrolling
Phase 4

Conditions

Overweight and Obese Adults

Treatments

Drug: liraglutide combined with orlistat
Drug: liraglutide monotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07301437
KY-2025-202

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

experimental group
Experimental group
Treatment:
Drug: liraglutide combined with orlistat
control group
Active Comparator group
Treatment:
Drug: liraglutide monotherapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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