parallel randomized trial

NCT06256523

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

Type 2 diabetes (adults)NCT06256523S002776

Design

Randomized: 72
Start year: 2022
Treatment: 26 weeks, follow-up 29 weeks
Countries: China (15 sites)
Sponsor: Gan and Lee Pharmaceuticals (industry)
Eligibility: age 18 to 65; HbA1c 7.0 to 10.0 percent; BMI 18.5 to 35; eGFR 60 or more

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: none

Arms

Arm	Treatment	Background	Analyzed
A1	Bofanglutide (GZR18) 4 mg injection once weekly Part A GZR18 escalated to 4 mg	lifestyle: standard	21
A2	Placebo Part A placebo	lifestyle: standard	8
A3	bofanglutide (GZR18) Part B GZR18 escalated to 13 mg	lifestyle: standard	21
A4	Placebo Part B placebo	lifestyle: standard	9

Baseline characteristics

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

Characteristic	Statistic	Bofanglutide (GZR18) 4 mg injection once weekly A1	Placebo A2	Part B GZR18 escalated to 13 mg A3	Placebo A4
age	mean (years)	53.6	53.0	54.8	49.7
age	sd (years)	11.5	10.1	10.1	11.6
bmi	mean (kg/m2)	26.8	27.0	27.1	25.8
bmi	sd (kg/m2)	3.4	4.2	3.8	2.8
diabetes duration	mean (years)	3.2	2.6	4.1	4.6
diabetes duration	sd (years)	3.5	2.4	4.5	3.7
female	n	16	3	8	4
female	percent	59.3	33.3	30.8	44.4
hba1c	mean (percent)	8.0	8.0	8.3	8.2
hba1c	sd (percent)	0.7	0.7	0.7	0.6
other han nationality	n	24	9	24	9
other han nationality	percent	88.9	100.0	92.3	100.0
waist	mean (cm)	94.8	95.1	95.0	91.2
waist	sd (cm)	10.2	12.7	9.5	6.5
weight	mean (kg)	72.9	77.5	76.1	72.2
weight	sd (kg)	14.2	16.6	13.0	13.1

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
23	A3	change	-1.81 percent		21	not stated; modified itt; R0002476:Results
23	A3 vs A4	md	-1.93 percent	-2.91 to -0.95		not stated; modified itt; R0002476:Results
23	A4	change	0.12 percent		9	not stated; modified itt; R0002476:Results
26	A1	change	-1.32 percent		21	not stated; modified itt; R0002476:Results
26	A1 vs A2	md	-2.18 percent	-2.79 to -1.57		not stated; modified itt; R0002476:Results
26	A2	change	0.86 percent		8	not stated; modified itt; R0002476:Results

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
23	A3	change	-6.92 kg		21	not stated; modified itt; R0002476:Results
23	A3 vs A4	md	-6.17 kg	-8.92 to -3.41		not stated; modified itt; R0002476:Results
23	A4	change	-0.76 kg		9	not stated; modified itt; R0002476:Results

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
23	A3	responders	57.7	15 / 26	not stated; full analysis; R0002476:Results
23	A4	responders		0 / 9	not stated; full analysis; R0002476:Results
26	A1	responders	55.6	15 / 27	not stated; full analysis; R0002476:Results
26	A2	responders		0 / 9	not stated; full analysis; R0002476:Results

Level 2 or 3 hypoglycemia (participants) (8 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	1 / 27	not stated; safety; R0002476:Results
A1	events	2 / 27	not stated; safety; R0002476:Table 2
A2	events	0 / 9	not stated; safety; R0002476:Table 2
A2	events	0 / 9	not stated; safety; R0002476:Table
A3	events	0 / 27	not stated; safety; R0002476:Results
A3	events	0 / 27	not stated; safety; R0002476:Table 2
A4	events	0 / 9	not stated; safety; R0002476:Results
A4	events	0 / 9	not stated; safety; R0002476:Table 2

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
23	A3	percent change	-9.25 percent		21	not stated; modified itt; R0002476:Results
23	A3 vs A4	md	-8.06 percent	-11.72 to -4.40		not stated; modified itt; R0002476:Results
23	A4	percent change	-1.19 percent		9	not stated; modified itt; R0002476:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				1 / 27	not stated; safety; R0002476:Results
	A4	events				0 / 9	not stated; safety; R0002476:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 27	not stated; safety; R0002476:Table 2
A2	events	0 / 9	not stated; safety; R0002476:Table 2
A3	events	2 / 27	not stated; safety; R0002476:Table 2
A4	events	0 / 9	not stated; safety; R0002476:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 27	not stated; safety; R0002476:Table 2
A2	events	0 / 9	not stated; safety; R0002476:Table 2
A3	events	3 / 27	not stated; safety; R0002476:Table 2
A4	events	0 / 9	not stated; safety; R0002476:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 27	not stated; safety; R0002476:Table 2
A2	events	1 / 9	not stated; safety; R0002476:Table 2
A3	events	10 / 27	not stated; safety; R0002476:Table 2
A4	events	0 / 9	not stated; safety; R0002476:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 27	not stated; safety; R0002476:Table 2
A2	events	0 / 9	not stated; safety; R0002476:Table 2
A3	events	3 / 27	not stated; safety; R0002476:Table 2
A4	events	1 / 9	not stated; safety; R0002476:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 27	not stated; safety; R0002476:Table 2
A2	events	1 / 9	not stated; safety; R0002476:Table 2
A3	events	8 / 27	not stated; safety; R0002476:Table 2
A4	events	2 / 9	not stated; safety; R0002476:Table 2

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

Arm	Statistic	Events / N	Detail
A1	events	1 / 27	not stated; safety; R0002476:Results
A2	events	0 / 9	not stated; safety; R0002476:Table 2
A3	events	2 / 27	not stated; safety; R0002476:Results
A4	events	0 / 9	not stated; safety; R0002476:Table 2

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 27	not stated; safety; R0002476:Results
A2	events	0 / 9	not stated; safety; R0002476:Results
A3	events	0 / 27	not stated; safety; R0002476:Results
A4	events	0 / 9	not stated; safety; R0002476:Results

Medullary thyroid carcinoma (4 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 27	not stated; safety; R0002476:Results
A2	events	0 / 9	not stated; safety; R0002476:Results
A3	events	0 / 27	not stated; safety; R0002476:Results
A4	events	0 / 9	not stated; safety; R0002476:Results

Thyroid cancer (any) (4 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 27	not stated; safety; R0002476:Results
A2	events	0 / 9	not stated; safety; R0002476:Results
A3	events	0 / 27	not stated; safety; R0002476:Results
A4	events	0 / 9	not stated; safety; R0002476:Results