NCT05285397

Brief Summary

Our primary objective is to assess the effect of Liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. We set out to assess if Liraglutide is a viable option to augment weight loss in said category.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 9, 2022

Last Update Submit

March 9, 2022

Conditions

Keywords

LiraglutideMorbid obesitysecondary bariatric surgeryrevisional bariatric surgery

Outcome Measures

Primary Outcomes (2)

  • Percentage Total weight loss

    6 months

  • Percentage Excess body weight loss

    6 months

Secondary Outcomes (10)

  • Comorbidities

    6 months

  • Weight

    6 months

  • BMI

    6 months

  • HbA1C

    6 months

  • Fasting Blood Glucose (FBG)

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

drug starts 6 weeks post-operative until 6 months SC injection dose starting 0.6 mg/day and weekly up titrated until 3.0 mg/day

Drug: Liraglutide Pen Injector [Saxenda]

Control

NO INTERVENTION

Patients with no weight loss drug intervention after bariatric surgery

Interventions

Subcutaneous injection of GLP-1 agonist

Liraglutide

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergone primary bariatric surgery
  • Need secondary bariatric surgery due to either weight regain (regained weight to have BMI \> 35) or medical associated diseases

You may not qualify if:

  • Prior use of GLP-1 agonist
  • Past history of pancreatitis
  • Personal or family history of medullary thyroid cancer
  • Pregnancy or lactation
  • Acute coronary syndrome
  • Hepatic or renal dysfunction
  • Active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madina Women's Hospital

Alexandria, 21531, Egypt

Location

Related Publications (1)

  • Thakur U, Bhansali A, Gupta R, Rastogi A. Liraglutide Augments Weight Loss After Laparoscopic Sleeve Gastrectomy: a Randomised, Double-Blind, Placebo-Control Study. Obes Surg. 2021 Jan;31(1):84-92. doi: 10.1007/s11695-020-04850-4. Epub 2020 Jul 12.

    PMID: 32656729BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mohamed Ashour, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. of General surgery

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 17, 2022

Study Start

March 10, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations