The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients

NCT04605861 | Completed Phase 3

• 1 other identifier: JSWB-LRG2020-301
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese or overweight adult patients with comorbidity of metabolic disorders.

Conditions

Obese; Overweight

Keywords

weight loss; obeses; overwweight; Liraglutide

Outcome Measures

Primary Outcomes (2)

• The percentage of body weight loss

  The percentage of body weight loss from baseline to the end of treatment

  through study completion, an average of 32 weeks

• The proportion of body weight loss ≥ 5 percent

  The proportion of subjects whose body weight loss is greater than ≥ 5 percent from baseline level to the end of treatment

  through study completion, an average of 32 weeks

Secondary Outcomes (9)

• Changes in waist circumference

  through study completion, an average of 32 weeks

• Changes in diastolic pressure and systolic pressure

  through study completion, an average of 32 weeks

• Changes in pulse of the subjects

  through study completion, an average of 32 weeks

• The changes in blood lipid

  through study completion, an average of 32 weeks

• The changes in blood glucose

  through study completion, an average of 32 weeks

Study Arms (2)

Liraglutide

EXPERIMENTAL

Liraglutide Injection, once a day, injected subcutaneously on abdomen, thigh or upper arm.

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Placebo (Liraglutide Injection simulator), once a day, injected subcutaneously on abdomen, thigh or upper arm.

Drug: Placebo

Interventions

Liraglutide DRUG

Liraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.

Liraglutide

Placebo DRUG

Placebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those voluntarily participating and signing the ICF.
• Those aged 18-70 years old (including 18 and 70 years old), without restriction on male and female
• Those failing to control their body weight in previous diet therapy alone.
• Those voluntarily following the medication, diet and exercise requirements decided by the investigators.
• Those with a stable body weight (patient reported body weight change \< 5 kg) in last 3 months.
• Those with BMI ≥ 30 kg/m2 (obese) or BMI ≥ 27 kg/m2 (overweight) accompanied by at least one treated or untreated related metabolic abnormality (hypertension, dyslipidemia, type 2 diabetes). Those with untreated hypertension defined as SBP ≥ 140 mmHg or DBP ≥ 90 mmHg; untreated dyslipidemia defined as LDL-C ≥ 4.1 mmol/L, TG ≥ 1.7 mmol/L, TC ≥ 5.7 mmol/L or HDL-C \< 1.0 mmol/L in male and \< 1.3 mmol/L in female.
• Those diagnosed as type 2 diabetes according to WHO (1999) Diagnostic and Classification Criteria at the time of screening;
• Those receiving diet and exercise therapy alone, or receivig metformin, sulfonylureas, glycosidase inhibitors and glinides alone or in combination on the basis of diet and exercise therapy, with their treatment remaining stable at least 3 months before screening (with original documents such as prescriptions provided);
• Those with HbA1c of 7.0-10.0% (inclusive);
• Those with FPG \< 13.3 mmol/L (240 mg/dL).

You may not qualify if:

• Those with type 1 diabetes or secondary diabetes.
• Those with acute metabolic complications such as diabetic ketoacidosis or hyperglycemia (coma) within 6 months before screening.
• Those with 2 or more severe hypoglycemia events (hypoglycemia with severe cognitive impairment and need other measures to help them recover) without obvious inducement within 3 months before screening.
• Those receiving GLP-1 receptor agonist, DPP-4 inhibitors, SGLT-2 inhibitor, or insulin therapy within 3 months prior to screening.
• Those with obesity caused by endocrine diseases such as Cushing's syndrome.
• Patients taking drugs that can significantly increase weight in the 3 months before screening, including systemic glucocorticoid (except cumulative or continuous use of less than 14 days).
• Those using OTC weight-loss drugs or appetite inhibitors (including traditional Chinese medicine as weight-loss drugs) within 1 month before screening, or use prescription weight-loss drugs (such as fentanyl, sibutramine, orlistat) or lipid dissolving injection (such as fat dissolving needle) within 3 months before screening.
• Those with binge eating behavior in the past, that is, eating a large amount of food in a short period of time with a sense of loss of control.
• Those who have treated or plan to treat obesity (during the trial) with surgery or body weight loss devices.
• Those with a past or family history of MTC (grandparents, parents, siblings), or those whose genetic diseases are prone to induce MTC and MEN2.
• Those with thyroid nodules of unknown etiology at the time of screening which is considered clinically significant by the investigator (calcitonin is more than 50 pg/ml, which is only allowed to be retested once).
• Those with a past history or found to have hyperthyroidism or hypothyroidism or subclinical hypothyroidism at the time of screening \[TSH \> 6 mIU/L\].
• Those with history of pancreatic cancer, acute or chronic pancreatitis, or with acute or chronic pancreatitis at the time of screening, or having blood amylase or lipase ≥ 3 times ULN.
• Those with acute gallbladder disease (cholecystitis, gallstone) more than 2 times in 1 year before screening.
• Those with MDD, anxiety disorder or other mental illnesses or with the PHQ-9 score ≥ 15 at screening

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hosital, Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Xiaoying Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Regardless of treatment allocations, each subject receive the same total volume of investigational drug or placebo. All drug automatic injectors and kits, study drugs or placebo are identical in appearance and labels to blind subjects and investigators. This can minimize the bias of investigators and subjects on treatment evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34\~36 weeks, including 2-week screening, 6\~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 28, 2020
• Study Start: August 18, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 15, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)