Saxenda: Underlying Mechanisms and Clinical Outcomes

NCT02944500 | Active Not Recruiting Phase 4

• 1 other identifier: 2015P000327
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to investigate the effect of treatment with the study drug Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food intake.

Conditions

Obesity

Keywords

Brain; Liraglutide; MRI

Outcome Measures

Primary Outcomes (1)

• BOLD response to food cues

  effect size of BOLD response to food cues in the brain

  5 weeks

Study Arms (2)

Liraglutide followed by placebo

EXPERIMENTAL

Participants will receive liraglutide with dose titration over 5 weeks (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of placebo for the same amount of time.

Drug: liraglutide; Other: Placebo

Placebo followed by liraglutide

EXPERIMENTAL

Participants will receive placebo with dose titration (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of liraglutide for the same amount of time.

Drug: liraglutide; Other: Placebo

Interventions

liraglutide DRUG

Also known as: Saxenda

Liraglutide followed by placebo; Placebo followed by liraglutide

Placebo OTHER

Liraglutide followed by placebo; Placebo followed by liraglutide

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese: BMI\> 30 kg/m2 or \>27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis).

You may not qualify if:

• Women who are breastfeeding, pregnant, or wanting to become pregnant.
• Women using metal IUD
• Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study.
• Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease
• Moderate, or severe hepatic impairment
• Hypersensitivity to the active substance or any of the excipients in liraglutide
• History of diabetic ketoacidosis
• Congestive heart failure
• EKG abnormalities (as listed above)
• Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc
• Gastroparesis
• Pancreatitis
• Gallstones- as they may cause increased risk of pancreatitis
• Alcohol consumption- the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia.
• Untreated thyroid disease like hypothyroidism or hyperthyroidism

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center General Clinical Research Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Angelidi AM, Kokkinos A, Sanoudou D, Connelly MA, Alexandrou A, Mingrone G, Mantzoros CS. Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity. Metabolism. 2023 Jan;138:155346. doi: 10.1016/j.metabol.2022.155346. Epub 2022 Nov 12.

  PMID: 36375643 DERIVED

• Peradze N, Farr OM, Perakakis N, Lazaro I, Sala-Vila A, Mantzoros CS. Short-term treatment with high dose liraglutide improves lipid and lipoprotein profile and changes hormonal mediators of lipid metabolism in obese patients with no overt type 2 diabetes mellitus: a randomized, placebo-controlled, cross-over, double-blind clinical trial. Cardiovasc Diabetol. 2019 Oct 31;18(1):141. doi: 10.1186/s12933-019-0945-7.

  PMID: 31672146 DERIVED

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 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: November 1, 2016
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)