Morbid ObesityNCT05285397
Effect of Liraglutide on Weight Loss in Patients Who Have Undergone Revisional Bariatric Surgeries.
A study testing Liraglutide Pen Injector [Saxenda] in people with Morbid Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Liraglutide Pen Injector [Saxenda]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergone primary bariatric surgery
- Need secondary bariatric surgery due to either weight regain (regained weight to have BMI > 35) or medical associated diseases
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Madina Women's Hospital
Alexandria, 21531
Mohamed Ashour, PhD, 00201002600970, dr.mhany@gmail.com
About this study
Official title: Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.
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.
- Conditions
- Morbid Obesity
- Being tested
- Liraglutide Pen Injector [Saxenda]
- Keywords
- Liraglutide, Morbid obesity, secondary bariatric surgery, revisional bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide Pen Injector [Saxenda]Drug
Subcutaneous injection of GLP-1 agonist
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Liraglutide Pen Injector [Saxenda] |
| Control | No intervention | Patients with no weight loss drug intervention after bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Total weight loss
Measured: 6 months
Percentage Excess body weight loss
Measured: 6 months
Secondary outcomes (10)
Comorbidities
Measured: 6 months
Weight
Measured: 6 months
BMI
Measured: 6 months
HbA1C
Measured: 6 months
Fasting Blood Glucose (FBG)
Measured: 6 months
HOMA-IR
Measured: 6 months
Resolution of type 2 Diabetes Mellitus
Measured: 6 months
Blood pressure
Measured: 6 months
Lipid profile
Measured: 6 months
Sleep apnea
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start10 Mar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285397
- Sponsor's protocol ID
- Liraglutide1
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32656729
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.
- ClinicalTrials.gov ID
- NCT05285397
- Acronym / sponsor ID
- Liraglutide1
- Conditions
- Morbid Obesity
- Keywords
- Liraglutide, Morbid obesity, secondary bariatric surgery, revisional bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 10 Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: Liraglutide Pen Injector [Saxenda]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 |
| Control | No intervention | –Patients with no weight loss drug intervention after bariatric surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergone primary bariatric surgery
- Need secondary bariatric surgery due to either weight regain (regained weight to have BMI > 35) or medical associated diseases
Key exclusion criteria (7 listed)
- Prior use of GLP-1 agonist
- Past history of pancreatitis
- Personal or family history of medullary thyroid cancer
- Pregnancy or lactation
- Acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide Pen Injector [Saxenda]Subcutaneous injection of GLP-1 agonist | Drug | Liraglutide |
Primary outcome
Percentage Total weight loss
Time frame: 6 months
Percentage Excess body weight loss
Time frame: 6 months
10 secondary outcomes
Comorbidities
Time frame: 6 months
Weight
Time frame: 6 months
BMI
Time frame: 6 months
HbA1C
Time frame: 6 months
Fasting Blood Glucose (FBG)
Time frame: 6 months
HOMA-IR
Time frame: 6 months
Resolution of type 2 Diabetes Mellitus
Time frame: 6 months
Blood pressure
Time frame: 6 months
Lipid profile
Time frame: 6 months
Sleep apnea
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 32656729Thakur 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.
- Individual participant dataSharing planned: Undecided
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide Pen Injector [Saxenda] in people with Morbid Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ashour, PhD (00201002600970, dr.mhany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Total weight loss (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.