Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response

NCT03341429 | Completed Phase 4

• 1 other identifier: 17/0238
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery

Conditions

Obesity

Keywords

obesity; GLP-1; liraglutide; diabetes; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• %WL

  The primary objective of this trial is to compare the efficacy of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration, as an adjunct to diet and exercise, on %WL in participants with poor weight-loss and a sub-optimal active GLP-1 response following primary RYGB or SG at the end of the 24-week treatment period.

  24 weeks

Secondary Outcomes (17)

• %fat

  24 weeks

• Skeletal muscle mass

  24 weeks

• Bone mineral density

  24 weeks

• Glucose level

  24 weeks

• Insulin

  24 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Daily subcutaneous injection of liraglutide 3.0 mg Study dosing of liraglutide: Week 1: 0.6 mg once daily Week 2: 1.2 mg once daily Week 3: 1.8 mg once daily Week 4: 2.4 mg once daily Week 5-24: 3.0 mg once daily In addition to the daily injection of liraglutide/placebo, participants in both groups will be advised to cut down approximately 500 calories from their usual food intake and to achieve a minimum of 150 minutes per week of physical activity.

Drug: Liraglutide Pen Injector [Saxenda]

Control

PLACEBO COMPARATOR

Daily subcutaneous injection of placebo; the same dosage regimen as treatment to be followed. In addition to the daily injection of liraglutide/placebo, participants in both groups will be advised to cut down approximately 500 calories from their usual food intake and to achieve a minimum of 150 minutes per week of physical activity.

Drug: Placebo

Interventions

Liraglutide Pen Injector [Saxenda] DRUG

Daily injection of GLP-1 agonist (liraglutide 3.0 mg) for obese patients presenting poor weight loss (\<20%) after bariatric surgery and suboptimal GLP-1 levels.

Also known as: Saxenda

Treatment

Placebo DRUG

Daily subcutaneous injection

Control

Eligibility Criteria

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

You may qualify if:

• Patients, 1 year or more after primary RYGB or primary SG, with poor weight-loss (\<20% WL) that is not caused by either a surgical or psychological problem.
• Adults, 18-64 years inclusive.
• Suboptimal nutrient-stimulated GLP-1 response assessed by a meal test. Suboptimal active GLP-1 response is defined as a ≤2-fold increase in active GLP-1 circulating levels between time 0 and time 30 minutes.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control, abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• ≤5 % variation in body weight over preceding 3 months.
• Fluent in English and able to understand and complete questionnaires.
• Willing and able to provide written informed consent and comply with the trial protocol.

You may not qualify if:

• Had a surgical procedure other than gastric bypass and sleeve gastrectomy.
• Pregnant or lactating mothers.
• Participation in other clinical intervention trial.
• Lifetime history of suicidal behaviour or severe depression assessed by direct questioning.
• Clinically significant medical abnormalities (e.g., unstable hypertension, clinically significant ECG abnormalities, liver cirrhosis, AST or ALT \> 3x the upper normal limit).
• Heart rate ≥ 100 beats/minute at screening on two separate measurements.
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Renal impairment (estimated glomerular infiltration rate (eGFR \<30 ml/min 1.73 m2)
• Known or suspected hypersensitivity to liraglutide 3.0 mg and placebo or any of the excipients involved in their formulation.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Personal history of pancreatitis.
• Uncontrolled hypothyroidism or hyperthyroidism.
• History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
• History of arrhythmias.
• Inflammatory bowel disease.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCLH

London, NW1 2BU, United Kingdom

Location

Related Publications (19)

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  PMID: 37494014 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rachel L Batterham, PhD FRCP

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator who will conduct the follow-up assessments and the trial subjects will be blinded to participants' allocation and will not be involved in delivering any of the intervention. The statistician conducting the data analysis will be blind to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a double-blind, randomised, placebo-controlled, two-arm, parallel group, single-site trial

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 14, 2017
• Study Start: August 22, 2018
• Primary Completion: November 28, 2019
• Study Completion: June 11, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: If participants agree by signing the option on the consent form, all of the listed above will be transferred to the ORBiS biobank at the end of the study and will be store there indefinitely, or till further use.

Locations

GB (1)