Overweight and Obese AdultsPhase 4NCT07301437

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

A Phase 4 study testing liraglutide monotherapy and liraglutide combined with orlistat in people with Overweight and Obese Adults, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

To evaluate the differences in weight loss between liraglutide monotherapy and combined with orlistat in overweight/obese patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Overweight and Obese Adults
What is being tested?: liraglutide monotherapy and liraglutide combined with orlistat
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: 1 May 2026to 31 Aug 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

About this study

Official title: 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.

Conditions: Overweight and Obese Adults
Being tested: liraglutide monotherapy, liraglutide combined with orlistat
Medical subject headings: Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutide monotherapyDrug
liraglutide monotherapy
liraglutide combined with orlistatDrug
combination therapy

Study groups in NCT07301437
Study group	Role	What they receive
experimental group	Experimental	Not described Receives: Drug: liraglutide combined with orlistat
control group	Active comparator	Not described Receives: Drug: liraglutide monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

weight loss
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202631 Aug 2027

First posted24 Dec 2025
Study start1 May 2026 (estimated)
Primary completion31 Aug 2027 (estimated)
Study completion31 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overweight and Obese AdultsStudies of the same condition, open and under way.
More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07301437
Sponsor's protocol ID: KY-2025-202
Status last verified: Mar 2026
First submitted: 11 Dec 2025
Last updated: 23 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Overweight and Obese Adults trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-world Study of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.
ClinicalTrials.gov ID: NCT07301437
Acronym / sponsor ID: KY-2025-202
Conditions: Overweight and Obese Adults
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
Study start: 1 May 2026 (estimated)
Primary completion: 31 Aug 2027 (estimated)
Study completion: 31 Aug 2027 (estimated)
First posted: 24 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Drug: liraglutide combined with orlistat
control group	Active comparator	Drug: liraglutide monotherapy

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutide monotherapyliraglutide monotherapy	Drug	control group
liraglutide combined with orlistatcombination therapy	Drug	experimental group

Primary outcome

weight loss
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.

Related trials for Overweight and Obese Adults

Recruiting
Exercise Training and Vitamin D Metabolism
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Recruiting
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RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
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RecruitingPhase 3
A Study to Learn About Safety and Effects of Once-monthly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JM)
Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight loss (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07301437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.