parallel randomized trial

NCT03619330

Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.

Other conditions NCT03619330S001291

Design

Randomized: 30
Start year: 2014
Treatment: 16 weeks, follow-up 16 weeks
Countries: Slovenia
Sponsor: University Medical Centre Ljubljana (non industry)
Eligibility: men 18 to 65; BMI 30 or more; functional hypogonadism, testosterone below 11 nmol/L

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Testosterone Testosterone replacement (TRT)	lifestyle measures promoted; lifestyle: standard		15
A2	Liraglutide 3.0 mg subcutaneous once daily LIRA arm	lifestyle advice; lifestyle: standard		15

Baseline characteristics

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

Characteristic	Statistic	Testosterone A1	Liraglutide 3.0 mg subcutaneous once daily A2	Whole trial ALL
age	mean (years)	49.3	43.9
age	sd (years)	9.8	11.6
bmi	mean (kg/m2)	39	43.2
bmi	sd (kg/m2)	9	7.5
hba1c	mean (percent)	6.4	5.9
hba1c	sd (percent)	1.3	0.8
other male	n			30
sbp	mean (mmHg)	150	144
sbp	sd (mmHg)	16	12
waist	mean (cm)	125	128
waist	sd (cm)	23	14
weight	mean (kg)	123	134
weight	sd (kg)	29	18

Results

24 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
	A1	events				0 / 15	not stated; safety; R0025206:Results

Health related quality of life total score (any instrument) (4 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-9.1 points	7	15	not stated; other; R0025206:Table 2
16	A1	final	31.5 points	5.7	15	not stated; other; R0025206:Table 1
16	A2	change	-4.8 points	10.3		not stated; other; R0025206:Table 2
16	A2	final	37.6 points	12.3		not stated; other; R0025206:Table 1

Serious adverse events (1 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results
	A2	events				4 / 15	not stated; safety; R0025206:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Nonarteritic anterior ischemic optic neuropathy (1 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Death by suicide (1 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Gastroparesis (1 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Intestinal obstruction or ileus (1 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results

Any cancer (1 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; safety; R0025206:Results