Gut Microbiome Changes Following Liraglutide Treatment in Obese Subjects or Overweight Subjects With Co-morbidities

NCT04525300 | Unknown Phase 3

• 1 other identifier: 202005062
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300 non-diabetic obese subjects or overweight subjects with co-morbidities were randomly assigned. Eligible participants were randomized 2:1 to once-daily subcutaneous injections of either liraglutide or placebo. The primary outcome is to investigate the composition of the gut microbiota from baseline to end of treatment.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• The composition of the gut microbiota from baseline to end of treatment.

  The composition of the gut microbiota from baseline to end of treatment compared to placebo.

  week 28

Study Arms (2)

Liraglutide

EXPERIMENTAL

Subject receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.

Drug: Liraglutide

placebo

PLACEBO COMPARATOR

Subject receiving placebo 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.

Drug: placebo

Interventions

Liraglutide DRUG

Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification

Also known as: S20200402

Liraglutide

placebo DRUG

Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification

Also known as: S20200301

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

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 Officials

• Jing Wu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wu

CONTACT

+86-13574120508; wujing0731@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 25, 2020
• Study Start: May 24, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

CN (1)