The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

NCT04839237 | Withdrawn Phase 2

• 1 other identifier: 201710832
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Weight Change at 3 months

  Measured in kilograms

  baseline and 3 months

• Genotype

  baseline

Secondary Outcomes (13)

• Change in waist circumference

  baseline and 3 months

• Change in systolic blood pressure

  baseline and 3 months

• Change in diastolic blood pressure

  baseline and 3 months

• Change in HbA1c

  baseline and 3 months

• Change in plasma glucose

  baseline and 3 months

Study Arms (2)

Liraglutide

EXPERIMENTAL

Obese patients with HbA1C lower than 9.0%,receive Liraglutide alone for 3 months.

Drug: Liraglutide

Liraglutide combined with metformin

EXPERIMENTAL

Obese patients with HbA1C ≥9.0%, receive Liraglutide in combination with metformin for 3 months.

Drug: Liraglutide;metformin

Interventions

Liraglutide DRUG

The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards,1.8mg per day, subcutaneous injection.

Also known as: Victoza

Liraglutide

Liraglutide;metformin DRUG

The treatment of Liraglutide combined with metformin lasted three months.For Liraglutide,during the first week: 0.6mg per day, subcutaneous injection;during the second week: 1.2mg per day, subcutaneous injection; from third week onwards,1.8mg per day, subcutaneous injection.For metformin,during three months:0.5g each time, 3 times per day,oral.

Also known as: Victoza;Glucophage

Liraglutide combined with metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 65 years (to the date of screening)；
• The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
• Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
• Weight stable for more than 3 months (weight fluctuations \<5%).

You may not qualify if:

• Pregnant female.
• Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
• Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
• Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
• Nearly a month had surgery, trauma, infection and so on.
• Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
• Poor medication compliance or serious side effects (severe rash, syncope, etc.).

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 9, 2021
• Study Start: December 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

CN (1)