3mg Liraglutide for Overweight or Obesity

NCT03885297 | Completed DMC

• 2 other identifiers: GD410218250896
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

In this study investigators will investigate the beneficial metabolic sequelae of Liraglutide in patients with obesity or overweight; including changes in vital signs, anthropometric characteristics (weight, body mass index and body composition), biochemical parameters, metabolomics and micro-ribonucleotide acid (miRNA) molecules from blood tests. Liraglutide is a commercially available analogue of a gut hormone physiologically produced in our bowel in response to food, licenced for the treatment of overweight or obesity. Liraglutide will be offered to patients attending National Health System (NHS) or private clinics within indication and according to their agreed clinical management. Investigators aim to collect real-life information for this study along with planned clinical management from patients who agree to their treatment and to take part in our study. Patients will be able to withdraw from treatment and study at any time without giving any explanation. If successful, this study will help us combine clinical, biochemical and molecular information which will allow us to gain deeper understanding on the mechanisms behind the beneficial metabolic effects of Liraglutide in overweight and obesity. Data generated from this study will hopefully help us acquire funding for a larger multicentre study; the results of which can have substantial impact on millions of people with overweight or obesity around the world.

Conditions

Overweight; Obesity; Infertility, Female

Keywords

obesity; metabolism; liraglutide; saxenda; metabolomics; miRNA; weight loss

Outcome Measures

Primary Outcomes (1)

• Weight changes related to treatment

  Weight reduction in kilograms from baseline while on treatment with 3mg Liraglutide once daily in patients with overweight (BMI: ≥27Kg/m2) or obesity (BMI: ≥30Kg/m2) with regards to:

  6 months

Secondary Outcomes (10)

• Changes in fat and lean mass while on treatment

  6 months

• Changes in an untargeted study of water-soluble metabolites (HILIC LCMS) while on treatment

  6 months

• Changes in an untargeted study of lipid metabolites (C18 reversed phase LCMS) while on treatment

  6 months

• Changes in the expression of miRNA-155 while on treatment.

  6 months

• Changes in the expression of miRNA-221 while on treatment.

  6 months

Study Arms (1)

Overweight/obese participants

Patients will be recruited prospectively from the weight management and Polycystic Ovary Syndrome (PCOS) clinics at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust following discussion with their treating physician, who will also be a member of the research team and joint agreement on initiation of treatment with 3mg Liraglutide once daily as per clinical management plan. Patients will additionally receive standard NHS Tier 3 lifestyle advice and support for the duration of the study. Lifestyle modification aimed at weight loss will be delivered by a dietician or other trained health care professional within individual sessions for a period of 6 months. Finally, all patients will be able to withdraw from treatment and/or the study at any point without giving any explanation. This will have no impact in their clinical management.

Drug: Saxenda; Other: Lifestyle modification; Diagnostic Test: Metabolomics; Diagnostic Test: miRNA

Interventions

Saxenda DRUG

Obesity pharmacotherapy

Overweight/obese participants

Lifestyle modification OTHER

Tier 3 NHS weight management

Overweight/obese participants

Metabolomics DIAGNOSTIC_TEST

Small molecule intermediates and products of metabolism

Overweight/obese participants

miRNA DIAGNOSTIC_TEST

Small non-coding RNA molecules

Overweight/obese participants

Eligibility Criteria

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

Study Population

Investigators don't anticipate any specific difficulties with recruitment for this study as overweight and obesity are very common conditions, and there are very few licensed medical options offering substantial weight loss. Liraglutide is one of them. Additionally, investigators don't see any specific difficulties in managing this study as it will be " part and parcel" of our patients' routine clinical visits. Liraglutide is going to be offered to our patients as per clinical need and the decision to treat them with liraglutide is going to be made before their potential participation in our study. Patients therefore are not going to be receiving treatment because of their participation in our study.

You may qualify if:

• Adult participants \[age ≥18 y.o without upper age limit (to the discretion of the investigators)\].
• Body mass index (BMI) ≥ 30 kg/m2 without coexisting comorbidities or BMI ≥27Kg/m2 with comorbidities like hypertension, hyperlipidaemia, prediabetes or obstructive sleep apnoea.
• Willing to comply with study requirements and able to give informed consent.

You may not qualify if:

• Type 1 or Type 2 diabetes mellitus
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease
• Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
• Persistent anaemia, defined as haemoglobin\<10 g/dl
• Chronic or acute renal impairment (eGFR \<30 ml/min/1.73m2)
• Active systemic infection (sepsis)
• Active malignancy within the last 5 years, including any form of thyroid cancer (including sporadic or familial medullary thyroid cancer) or personal, or family history of Multiple Endocrine Neoplasia type 2.
• Active illicit substance abuse or alcoholism
• Current pregnancy or breastfeeding at screening or 6 months previously
• Donated blood during the preceding 3 months or intention to do so before the end of the study.
• Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Kingston University: collaborator
• University of Warwick: collaborator
• University of Birmingham: collaborator

Study Sites (1)

WISDEM Centre, University Hospitals Coventry and Warwickshire

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Related Publications (9)

• James WP. WHO recognition of the global obesity epidemic. Int J Obes (Lond). 2008 Dec;32 Suppl 7:S120-6. doi: 10.1038/ijo.2008.247.

  PMID: 19136980 BACKGROUND

• WHO annual report 2017; Obesity update - © OECD 2017

  BACKGROUND

• http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm198638.htm

  BACKGROUND

• FDA approves weight-management drug Saxenda

  BACKGROUND

• Daviss, Bennett (April 2005).

  BACKGROUND

• Jordan KW, Nordenstam J, Lauwers GY, Rothenberger DA, Alavi K, Garwood M, Cheng LL. Metabolomic characterization of human rectal adenocarcinoma with intact tissue magnetic resonance spectroscopy. Dis Colon Rectum. 2009 Mar;52(3):520-5. doi: 10.1007/DCR.0b013e31819c9a2c.

  PMID: 19333056 BACKGROUND

• Ambros V. The functions of animal microRNAs. Nature. 2004 Sep 16;431(7006):350-5. doi: 10.1038/nature02871.

  PMID: 15372042 BACKGROUND

• Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.

  PMID: 14744438 BACKGROUND

• Extracellular/Circulating MicroRNAs: Release Mechanisms, Functions and Challenges

  BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Infertility, Female; Weight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; 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

• Georgios K. Dimitriadis

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 21, 2019
• Study Start: January 18, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)