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UnknownPhase 3

Efficacy and Safety of Liraglutide on Body Weight in Obese Subjects or Overweight Subjects With Co-morbidities

Efficacy and Safety of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 28-week Trial

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

300

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoints

Body weight, % change≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04487743
Org study ID202006108
Secondary IDHDSJ19LLLTHangzhou Zhongmei Huadong Pharmaceutical Co. , Ltd.

Timeline

Milestones

Study start2020-05-09actual
Study first posted2020-07-27actual
Last update posted2020-07-27actual
Primary completion2022-06estimated (month precision)
Study completion2022-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Informed consent obtained before any trial-related activity takes place
Obesity (BMI ≥30.0 kg/m2); or overweight (BMI ≥27.0 kg/m2) with treated or untreated co-morbid dyslipidemia (Low-density lipoprotein ≥3.38mmol/l (130 mg/dl), or triglycerides ≥1.7mmol/l (150 mg/dl), or high-density lipoprotein <1.04mmol/l (40 mg/dl) for males and <1.30mmol/l (50 mg/dl) for females) and/or hypertension (Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
Age ≥18 years, ≤75 years

Exclusion criteria

Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator
HbA1c ≥6.5% or fasting plasma glucose ≥7.0 mmol/l or 2-hour post-challenge plasma glucose ≥11.1 mmol/liter (at screening)
less than 5 kg self-reported change during the previous 3 months
Previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide) within the last 3 months
Known or suspected hypersensitivity to trial product, related products or other GLP-1 receptor agonist
Diet attempts using herbal supplements or over-the-counter medications within 1 months before screening, or use prescription drugs for weight loss within 3 months before screening (for example: orlistat, fenfluramine, maindole ) Or lipid dissolving injection (for example: lipolysis needle) treatment
Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (more than 1 week),tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptiline, mirtazapin, paroxetine, phenelzine, clorpromazine, thioridazine, clozapine, lanzapine, valproic acid and its derivatives, and lithium)
A history of malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical operation)
A history of severe heart disease is defined as: decompensated heart insufficiency (NYHA III-IV), and/or a history of unstable angina within 6 months before screening, and a history of myocardial infarction within 12 months
Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
Suffer from gastrointestinal motility disorders or obstruction diseases, such as gastroparesis, gastroesophageal reflux disease
Any lifetime history of a suicidal attempt or A history of any suicidal behavior in the last month prior to randomization
A patient health questionnaire (PHQ-9) score of ≥15
Montreal Cognitive Assessment Scale (MoCA) score <26 at screening;
Any suicidal ideation of type 4 or 5 on the Columbian Suicidality Severity Rating Scale (C-SSRS) in the last month prior to randomization
Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone >6 mIU/liter or <0.4 mIU/liter
Screening calcitonin ≥50 ng/liter
Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) or Personal history of non-familial medullary thyroid carcinoma
History of chronic pancreatitis or idiopathic acute pancreatitis or amylase ≥ 3 times the upper limit of normal value during screening
ALT or AST or TBiL>3 times the upper limit of normal value during screening
Impaired renal function, defined as serum creatinine level ≥1.5mg/dL (132µmol/L) in men or ≥1.4mg/dL (123µmol/L) in women at screening
Untreated or uncontrolled severe dyslipidemia, defined as blood LDL-C≥190mg/dl (4.94mmol/L) and/or TG≥500mg/dl (5.65mmol/L) at screening
Uncontrolled treated/untreated hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
According to the investigator's judgment, those who have a surgical plan during the trial period (except for minor operations)
Participated in any weight loss clinical trials within 3 months before screening, and took any experimental drugs within 1 month (Re-screening is allowed once within the limit of the recruitment period)
Known or suspected abuse of alcohol or narcotics within 6 months
Poor compliance with restrictions on diet and behavior during screening
Females of child-bearing potential who are pregnant, breast-feeding
Participants intend to become pregnant or are not using adequate contraceptive methods or subjects who use hormonal contraceptives
The investigator considers that it is not suitable for participants (for example, the investigator judges that severe obstructive sleep apnea will cause gastroesophageal reflux).

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

4 endpoints
Primary/protocol endpoint

Mean Change From Baseline in Fasting Body Weight

Time frame:Week 0, Week 28

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Time frame:Week 28

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Subjects Losing More Than 10% of Baseline Fasting Body Weight.

Time frame:Week 28

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Waist Circumference (cm)

Time frame:Week 0, Week 28

Waist circumference, change

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.