parallel randomized trial

DREAM

Dapiglutide for the Treatment of Obesity (DREAM): a Randomised, Double-blind, Placebo-controlled, Investigator-initiated Trial

Overweight or obesity without diabetes (adults)NCT05788601S002006

Design

Randomized: 54
Start year: 2023
Treatment: 12 weeks, follow-up 16 weeks
Countries: Denmark (1 sites)
Sponsor: University Hospital, Gentofte, Copenhagen (industry)
Eligibility: age 18 to 75; BMI 30 or more; no diabetes, HbA1c below 48 mmol/mol

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population
Missing data: multiple imputation

Arms

Arm	Treatment	Background	Randomized	Completed treatment
A1	Placebo Placebo	lifestyle: none	18	18
A2	Dapiglutide 4 mg injection once weekly Dapiglutide 4 mg	lifestyle: none	18	16
A3	Dapiglutide 6 mg injection once weekly Dapiglutide 6 mg	lifestyle: none	18	16

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Dapiglutide 4 mg injection once weekly A2	Dapiglutide 6 mg injection once weekly A3
age	median (years)	54.0	56.0	51.0
age	q1 (years)	49.8	43.5	47.5
age	q3 (years)	61.0	59.8	59.0
bmi: 30 to less than 35	n	10	10	8
bmi: 30 to less than 35	percent	56	56	44
bmi: 35 to less than 40	n	8	5	6
bmi: 35 to less than 40	percent	44	28	33
bmi: 40 or more	n	0	3	4
bmi: 40 or more	percent	0	17	22
bmi	median (kg/m2)	33.4	34.7	36.0
bmi	q1 (kg/m2)	31.3	32.0	31.1
bmi	q3 (kg/m2)	36.5	38.3	39.2
female	n	12	12	10
female	percent	67	67	56
hba1c	median (percent)	5.4	5.2	5.4
hba1c	q1 (percent)	5.2	5.0	5.3
hba1c	q3 (percent)	5.4	5.4	5.5
other ethnicity inuit	n	0	1	0
other ethnicity inuit	percent	0	6	0
sbp	median (mmHg)	129	133	130
sbp	q1 (mmHg)	120.8	117.8	125.3
sbp	q3 (mmHg)	140.8	145.5	141.5
waist	median (cm)	105.3	109.7	108.5
waist	q1 (cm)	100.9	105.3	103.5
waist	q3 (cm)	110.0	115.5	117.5
weight	median (kg)	96.4	100.9	106.0
weight	q1 (kg)	90.6	92.1	89.5
weight	q3 (kg)	105.5	106.1	112.9
white	n	18	17	18
white	percent	100	94	100

Analyses this trial contributes to

Results

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

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	change	-1 mmHg	-6.6 to 4.6	18	not stated; other; R0011013:Table 2
12	A2	change	-4 mmHg	-11.4 to 3.0	16	not stated; other; R0011013:Table 2
12	A3	change	-8 mmHg	-16.0 to -0.5	17	not stated; other; R0011013:Table 2
12	A3 vs A1	md	-5.3 mmHg	-12.9 to 2.2		not stated; other; R0011013:Table 2

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	percent change	-2.2 percent	-3.9 to -0.6	18	not stated; other; R0011013:Table 2
12	A2	percent change	-2.9 percent	-5.0 to -0.8	16	not stated; other; R0011013:Table 2
12	A3 vs A1	md	-2.1 percent	-3.8 to -0.5		not stated; other; R0011013:Table 2
12	A3 vs A1	md	-2.1 percent	-4.3 to 0.2		hypothetical; other; R0011013:Results
12	A3	percent change	-4.3 percent	-5.7 to -2.8	17	not stated; other; R0011013:Table 2

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders	22			4 /	not stated; other; R0011013:Results
12	A3	responders	47			8 /	not stated; other; R0011013:Results

Weight loss of 10 percent or more (3 lines; O11B)

Week	Arm	Statistic	Detail
12	A1	responders	not stated; other; R0011013:Results
12	A2	responders	not stated; other; R0011013:Results
12	A3	responders	not stated; other; R0011013:Results

Weight loss of 15 percent or more (3 lines; O11C)

Week	Arm	Statistic	Detail
12	A1	responders	not stated; other; R0011013:Results
12	A2	responders	not stated; other; R0011013:Results
12	A3	responders	not stated; other; R0011013:Results

Weight loss of 20 percent or more (3 lines; O11D)

Week	Arm	Statistic	Detail
12	A1	responders	not stated; other; R0011013:Results
12	A2	responders	not stated; other; R0011013:Results
12	A3	responders	not stated; other; R0011013:Results

Weight loss of 25 percent or more (3 lines; O11E)

Week	Arm	Statistic	Detail
12	A1	responders	not stated; other; R0011013:Results
12	A2	responders	not stated; other; R0011013:Results
12	A3	responders	not stated; other; R0011013:Results

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; randomized; R0011013:Table 3
A2	events	0 / 18	not stated; randomized; R0011013:Table 3
A3	events	1 / 18	not stated; randomized; R0011013:Table 3

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; randomized; R0011013:Table 3
	A2	events				0 / 18	not stated; randomized; R0011013:Table 3

Physical functioning (any instrument) (8 lines; O24B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	change	2.6 points	-6.9 to 12.1	18	not stated; other; R0011013:Table 2
12	A1	change	5.0 points	-3.4 to 13.4	18	not stated; other; R0011013:Table 2
12	A2	change	-8.7 points	-27.2 to 9.9	16	not stated; other; R0011013:Table 2
12	A2	change	10.7 points	-1.7 to 23.0	16	not stated; other; R0011013:Table 2
12	A3	change	2.8 points	-4.5 to 10.2	17	not stated; other; R0011013:Table 2
12	A3	change	-2.1 points	-14.6 to 10.5	17	not stated; other; R0011013:Table 2
12	A3 vs A1	md	-8.2 points	-22.1 to 5.6		not stated; other; R0011013:Table 2
12	A3 vs A1	md	-2.0 points	-12.8 to 8.8		not stated; other; R0011013:Table 2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; randomized; R0011013:Table 3
A2	events	0 / 18	not stated; randomized; R0011013:Table 3
A3	events	1 / 18	not stated; randomized; R0011013:Table 3

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; randomized; R0011013:Table 3
A1	events	0 /	not stated; other; R0011013:Results
A2	events	0 / 18	not stated; randomized; R0011013:Table 3
A2	events	0 /	not stated; other; R0011013:Results
A3	events	0 /	not stated; other; R0011013:Results
A3	events	0 / 18	not stated; randomized; R0011013:Table 3

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	7 / 18	not stated; randomized; R0011013:Table 3
A2	events	10 / 18	not stated; randomized; R0011013:Table 3
A3	events	10 / 18	not stated; randomized; R0011013:Table 3

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 18	not stated; randomized; R0011013:Table 3
A2	events	3 / 18	not stated; randomized; R0011013:Table 3
A3	events	1 / 18	not stated; randomized; R0011013:Table 3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 18	not stated; randomized; R0011013:Table 3
A2	events	6 / 18	not stated; randomized; R0011013:Table 3
A3	events	5 / 18	not stated; randomized; R0011013:Table 3

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	2 / 18	not stated; randomized; R0011013:Table 3
A2	events	3 / 18	not stated; randomized; R0011013:Table 3
A3	events	8 / 18	not stated; randomized; R0011013:Table 3

Discontinuation due to gastrointestinal adverse events (6 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; randomized; R0011013:Table 3
A1	events	0 /	not stated; other; R0011013:Results
A2	events	0 /	not stated; other; R0011013:Results
A2	events	0 / 18	not stated; randomized; R0011013:Table 3
A3	events	0 /	not stated; other; R0011013:Results
A3	events	0 / 18	not stated; randomized; R0011013:Table 3

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; randomized; R0011013:Table 3
A2	events	0 / 18	not stated; randomized; R0011013:Table 3
A3	events	0 / 18	not stated; randomized; R0011013:Table 3