parallel randomized trial

ACCESS

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity

Overweight or obesity without diabetes (adults)NCT06693843S000899

Design

Randomized: 230
Start year: 2024
Treatment: 36 weeks, follow-up 36 weeks
Countries: United States (38 sites)
Sponsor: Structure Therapeutics (industry)
Eligibility: age 18 to 79; BMI 30 or more, or 27 or more with comorbidity; HbA1c below 6.5 percent; weight above 80 kg; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Aleniglipron 45 mg tablet once daily Aleniglipron 45 mg	lifestyle: not reported	45	45	33
A2	Aleniglipron 90 mg tablet once daily Aleniglipron 90 mg	lifestyle: not reported	65	65	49
A3	Aleniglipron 120 mg tablet once daily Aleniglipron 120 mg	lifestyle: not reported	64	63	50
A4	Placebo Pooled placebo	lifestyle: not reported	56	56	42

Baseline characteristics

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

Characteristic	Statistic	Aleniglipron 45 mg tablet once daily A1	Aleniglipron 90 mg tablet once daily A2	Aleniglipron 120 mg tablet once daily A3	Placebo A4	Whole trial ALL
age	mean (years)	49.0	47.9	52.3	49.9	49.8
age	sd (years)	12.7	12.5	13.9	15.8	13.8
asian	n	1	2	0	1	4
asian	percent	2.2	3.1	0.0	1.8	1.7
black	n	5	8	5	6	24
black	percent	11.1	12.3	7.8	10.7	10.4
bmi	mean (kg/m2)	39.7	39.8	39.0	39.4	39.5
bmi	sd (kg/m2)	6.9	7.5	6.4	7.0	6.9
egfr	mean (mL/min/1.73m2)	99.0	100.2	98.8	100.5	99.6
egfr	sd (mL/min/1.73m2)	20.4	17.1	18.2	17.4	18.1
female	n	25	35	35	30	125
female	percent	55.6	53.8	54.7	53.6	54.3
hba1c	mean (percent)	5.7	5.7	5.7	5.5	5.6
hba1c	sd (percent)	0.3	0.4	0.3	0.4	0.4
hispanic	n	7	9	9	11	36
hispanic	percent	15.6	13.8	14.1	19.6	15.7
sbp	mean (mmHg)	127.0	126.4	125.3	125.3	125.9
sbp	sd (mmHg)	11.3	12.6	14.8	12.6	13.0
waist	mean (cm)	120.1	121.8	121.2	121.2	121.2
waist	sd (cm)	15.3	15.0	12.5	15.6	14.5
weight	mean (kg)	115.6	117.9	113.1	112.3	114.8
weight	sd (kg)	24.7	23.6	20.5	22.0	22.6
white	n	37	53	56	46	192
white	percent	82.2	81.5	87.5	82.1	83.5

Analyses this trial contributes to

Results

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

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
36	A1	change	-7.9 mmHg	1.71	-11.25 to -4.48	45	hypothetical; full analysis; R0000892:Extended Data Table 5
36	A2	change	-8.9 mmHg	1.42	-11.68 to -6.07	65	hypothetical; full analysis; R0000892:Extended Data Table 5
36	A3	change	-9.0 mmHg	1.40	-11.74 to -6.21	63	hypothetical; full analysis; R0000892:Extended Data Table 5
36	A4	change	-1.5 mmHg	1.52	-4.49 to 1.49	56	hypothetical; full analysis; R0000892:Extended Data Table 5

Percent body weight change (14 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
36	A1 vs A4	md	-7.9 percent	1.50	-10.81 to -4.90		treatment policy; full analysis; R0000892:Extended Data Table 2
36	A1	percent change	-9.0 percent		-11.2 to -6.8	45	hypothetical; full analysis; R0000892:Results
36	A1 vs A4	md	-8.2 percent		-11.1 to -5.3		hypothetical; full analysis; R0000892:Results
36	A1	percent change	-8.8 percent	1.13	-11.08 to -6.60	45	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A2	percent change	-10.7 percent		-12.5 to -8.8	65	hypothetical; full analysis; R0000892:Results
36	A2	percent change	-10.2 percent	0.94	-12.07 to -8.37	65	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A2 vs A4	md	-9.2 percent	1.36	-11.91 to -6.55		treatment policy; full analysis; R0000892:Extended Data Table 2
36	A2 vs A4	md	-9.8 percent		-12.5 to -7.2		hypothetical; full analysis; R0000892:Results
36	A3 vs A4	md	-11.3 percent		-13.9 to -8.6		hypothetical; full analysis; R0000892:Results
36	A3	percent change	-12.1 percent		-13.9 to -10.3	63	hypothetical; full analysis; R0000892:Results
36	A3	percent change	-11.4 percent	0.92	-13.26 to -9.62	63	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A3 vs A4	md	-10.5 percent	1.35	-13.11 to -7.80		treatment policy; full analysis; R0000892:Extended Data Table 2
36	A4	percent change	-0.8 percent		-2.7 to 1.1	56	hypothetical; full analysis; R0000892:Results
36	A4	percent change	-1.0 percent	0.99	-2.93 to 0.96	56	treatment policy; full analysis; R0000892:Extended Data Table 2

Weight loss of 5 percent or more (12 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	responders	70.1	55.19 to 81.69	45	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A1	responders	75.4	58.31 to 87.02	45	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A1	responders			25 / 33	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders			39 / 49	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders	79.5	66.16 to 88.49	65	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders	77.6	65.82 to 86.22	65	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A3	responders	85.9	73.57 to 92.98	63	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders			43 / 50	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders	77.0	64.93 to 85.79	63	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A4	responders			8 / 42	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A4	responders	22.7	12.20 to 38.26	56	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A4	responders	18.3	10.18 to 30.55	56	treatment policy; full analysis; R0000892:Extended Data Table 2

Weight loss of 10 percent or more (12 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	responders	44.2	28.45 to 61.24	45	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A1	responders	35.1	22.64 to 50.07	45	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A1	responders			14 / 33	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders	45.6	33.80 to 57.84	65	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A2	responders			27 / 49	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders	54.4	40.41 to 67.66	65	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders	61.2	48.59 to 72.47	63	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A3	responders	70.4	56.21 to 81.50	63	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders			36 / 50	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A4	responders	6.9	2.09 to 20.62	56	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A4	responders	4.3	1.24 to 13.83	56	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A4	responders			2 / 42	hypothetical; full analysis; R0000892:Extended Data Table 3

Weight loss of 15 percent or more (12 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	responders	13.5	6.29 to 26.75	45	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A1	responders	19.4	9.28 to 36.23	45	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A1	responders			6 / 33	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders			13 / 49	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A2	responders	21.5	13.09 to 33.33	65	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A2	responders	26.1	15.74 to 40.01	65	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders	37.9	25.38 to 52.29	63	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders			20 / 50	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A3	responders	30.8	20.57 to 43.40	63	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A4	responders	0.8	0.05 to 11.72	56	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A4	responders	1.0	0.07 to 14.15	56	hypothetical; full analysis; R0000892:Extended Data Table 3
36	A4	responders			0 / 42	hypothetical; full analysis; R0000892:Extended Data Table 3

Weight loss of 20 percent or more (4 lines; O11D)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	responders	5.6	1.66 to 17.36	45	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A2	responders	8.6	3.80 to 18.34	65	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A3	responders	15.0	8.09 to 26.12	63	treatment policy; full analysis; R0000892:Extended Data Table 2
36	A4	responders	0.9	0.06 to 12.31	56	treatment policy; full analysis; R0000892:Extended Data Table 2

Acute kidney injury (4 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; acute kidney injury; R0000892:Extended Data Table 1
A2	events	0 / 65	not stated; safety; acute kidney injury; R0000892:Extended Data Table 1
A3	events	3 / 63	not stated; safety; acute kidney injury; R0000892:Extended Data Table 1
A4	events	0 / 56	not stated; safety; acute kidney injury; R0000892:Extended Data Table 1

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; R0000892:Results
A2	events	0 / 65	not stated; safety; R0000892:Results
A3	events	0 / 63	not stated; safety; R0000892:Results
A4	events	0 / 56	not stated; safety; R0000892:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 45	not stated; safety; R0000892:Table 2
A2	events	0 / 65	not stated; safety; R0000892:Table 2
A3	events	4 / 63	not stated; safety; R0000892:Table 2
A4	events	3 / 56	not stated; safety; R0000892:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	6 / 45	not stated; safety; R0000892:Table 2
A2	events	5 / 65	not stated; safety; R0000892:Table 2
A3	events	7 / 63	not stated; safety; R0000892:Table 2
A4	events	3 / 56	not stated; safety; R0000892:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	32 / 45	not stated; safety; R0000892:Table 2
A2	events	44 / 65	not stated; safety; R0000892:Table 2
A3	events	41 / 63	not stated; safety; R0000892:Table 2
A4	events	12 / 56	not stated; safety; R0000892:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	18 / 45	not stated; safety; R0000892:Table 2
A2	events	29 / 65	not stated; safety; R0000892:Table 2
A3	events	20 / 63	not stated; safety; R0000892:Table 2
A4	events	3 / 56	not stated; safety; R0000892:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	19 / 45	not stated; safety; R0000892:Table 2
A2	events	26 / 65	not stated; safety; R0000892:Table 2
A3	events	14 / 63	not stated; safety; R0000892:Table 2
A4	events	13 / 56	not stated; safety; R0000892:Table 2

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	18 / 45	not stated; safety; R0000892:Table 2
A2	events	20 / 65	not stated; safety; R0000892:Table 2
A3	events	19 / 63	not stated; safety; R0000892:Table 2
A4	events	8 / 56	not stated; safety; R0000892:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	6 / 45	not stated; safety; R0000892:Table 2
A2	events	5 / 65	not stated; safety; R0000892:Table 2
A3	events	3 / 63	not stated; safety; R0000892:Table 2
A4	events	1 / 56	not stated; safety; R0000892:Table 2

Gallbladder and biliary disease (8 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; cholelithiasis; R0000892:Extended Data Table 1
A1	events	0 / 45	not stated; safety; cholecystitis; R0000892:Extended Data Table 1
A2	events	0 / 65	not stated; safety; cholelithiasis; R0000892:Extended Data Table 1
A2	events	0 / 65	not stated; safety; cholecystitis; R0000892:Extended Data Table 1
A3	events	0 / 63	not stated; safety; cholelithiasis; R0000892:Extended Data Table 1
A3	events	0 / 63	not stated; safety; cholecystitis; R0000892:Extended Data Table 1
A4	events	1 / 56	not stated; safety; cholecystitis; R0000892:Extended Data Table 1
A4	events	1 / 56	not stated; safety; cholelithiasis; R0000892:Extended Data Table 1

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; suicidal ideation; R0000892:Extended Data Table 1
A2	events	0 / 65	not stated; safety; suicidal ideation; R0000892:Extended Data Table 1
A3	events	1 / 63	not stated; safety; suicidal ideation; R0000892:Extended Data Table 1
A4	events	0 / 56	not stated; safety; suicidal ideation; R0000892:Extended Data Table 1