NCT07301437

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
16mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Aug 2027

First Submitted

Initial submission to the registry

December 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

December 11, 2025

Last Update Submit

March 20, 2026

Conditions

Overweight and Obese Adults

Outcome Measures

Primary Outcomes (1)

  • weight loss

    6 months

Study Arms (2)

experimental group

EXPERIMENTAL
Drug: liraglutide combined with orlistat

control group

ACTIVE COMPARATOR
Drug: liraglutide monotherapy

Interventions

liraglutide monotherapyDRUG

liraglutide monotherapy

control group
liraglutide combined with orlistatDRUG

combination therapy

experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Overweight

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03