parallel randomized trial

NCT05285397

Liraglutide's Effect on Weight Loss in Patients After Secondary Bariatric Surgery ; a Randomized Double-blind Controlled Study.

Other conditions NCT05285397S001245

Design

Randomized: 80
Start year: 2022
Treatment: 24 weeks, follow-up 52.18 weeks
Countries: Egypt (1 sites)
Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt (non industry)
Eligibility: age 18 to 60; insufficient weight loss or regain after sleeve gastrectomy undergoing conversional RYGB

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: per protocol
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 3.0 mg subcutaneous once daily Liraglutide	conversional Roux-en-Y gastric bypass 6 weeks earlier; lifestyle: standard	40	35	38
A2	Placebo Placebo	conversional Roux-en-Y gastric bypass 6 weeks earlier; lifestyle: standard	40	29	31

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Liraglutide 3.0 mg subcutaneous once daily A1	Placebo A2
age	mean (years)	38.21	37.16
age	sd (years)	9.06	12.81
bmi	mean (kg/m2)	35.85	36.18
bmi	sd (kg/m2)	0.93	0.87
female	n	25	24
female	percent	65.8	77.4
hba1c	mean (percent)	5.73	5.68
hba1c	sd (percent)	1.20	0.78

Results

23 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 40	not stated; randomized; R0015487:Results
	A2	events				0 / 40	not stated; randomized; R0015487:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 38	not stated; other; nausea and vomiting; R0015487:Results
	A2	events				0 / 40	not stated; safety; nausea and vomiting; R0015487:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 38	not stated; other; severe abdominal pain and vomiting; R0015487:Results
	A2	events				0 / 40	not stated; safety; severe abdominal pain and vomiting; R0015487:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Nonarteritic anterior ischemic optic neuropathy (1 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Death by suicide (1 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Gastroparesis (1 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Intestinal obstruction or ileus (3 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 40	not stated; randomized; small bowel obstruction; R0015487:Table 6
A2	events	0 / 40	not stated; randomized; small bowel obstruction; R0015487:Table 6
A2	events	0 / 40	not stated; safety; R0015487:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results

Any cancer (1 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; safety; R0015487:Results