parallel randomized trial

NCT05623839

A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677

Overweight or obesity without diabetes (adults)NCT05623839S001559

Design

Randomized: 32
Start year: 2022
Treatment: 20 weeks, follow-up 27 weeks
Countries: United States (2 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 to 70; BMI 27 to 50; HbA1c below 6.5 percent; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo (cohorts 1 and 2 pooled)	lifestyle: none	8	6
A2	mazdutide Mazdutide 16 mg cohort 1	lifestyle: none	12	10
A3	mazdutide Mazdutide 16 mg cohort 2	lifestyle: none	12	11

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Mazdutide 16 mg cohort 1 A2	Mazdutide 16 mg cohort 2 A3
age cohort:1	mean (years)	38.0
age cohort:1	se (years)	5.9
age cohort:2	mean (years)	29.0
age cohort:2	se (years)	7.5
age	mean (years)		33.8	40.7
age	se (years)		3.0	2.9
black cohort:1	n	1
black cohort:1	percent	25.0
black cohort:2	n	3
black cohort:2	percent	75.0
black	n		1	2
black	percent		8.3	16.7
bmi cohort:1	mean (kg/m2)	29.9
bmi cohort:1	se (kg/m2)	0.8
bmi cohort:2	mean (kg/m2)	35.3
bmi cohort:2	se (kg/m2)	3.1
bmi	mean (kg/m2)		33.0	32.0
bmi	se (kg/m2)		1.1	1.1
female cohort:1	n	1
female cohort:1	percent	25.0
female cohort:2	n	1
female cohort:2	percent	25.0
female	n		5	7
female	percent		41.7	58.3
hba1c cohort:1	mean (percent)	5.5
hba1c cohort:1	se (percent)	0.2
hba1c cohort:2	mean (percent)	5.4
hba1c cohort:2	se (percent)	0.1
hba1c	mean (percent)		5.3	5.3
hba1c	se (percent)		0.1	0.1
hispanic cohort:1	n	1
hispanic cohort:1	percent	25.0
hispanic cohort:2	n	1
hispanic cohort:2	percent	25.0
hispanic	n		4	10
hispanic	percent		33.3	83.3
waist cohort:1	mean (cm)	98.3
waist cohort:1	se (cm)	3.8
waist cohort:2	mean (cm)	111.7
waist cohort:2	se (cm)	7.6
waist	mean (cm)		109.6	102.0
waist	se (cm)		3.8	1.9
weight cohort:1	mean (kg)	91.9
weight cohort:1	se (kg)	4.5
weight cohort:2	mean (kg)	105.1
weight cohort:2	se (kg)	10.1
weight	mean (kg)		99.7	87.2
weight	se (kg)		5.7	3.2
white cohort:1	n	3
white cohort:1	percent	75.0
white cohort:2	n	1
white cohort:2	percent	25.0
white	n		11	10
white	percent		91.7	83.3

Analyses this trial contributes to

Results

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

Percent body weight change (6 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
19.57	A1	percent change	-0.1 percent	1.5	6	not stated; completers; R0013210:Results
19.57	A2	percent change	-20.0 percent	1.2	10	not stated; completers; R0013210:Results
19.57	A3	percent change	-21.0 percent	1.2	11	not stated; completers; R0013210:Results
27	A1	percent change	1.2 percent	1.6	6	not stated; completers; R0013210:Results
27	A2	percent change	-14.1 percent	1.3	10	not stated; completers; R0013210:Results
27	A3	percent change	-14.1 percent	1.2	11	not stated; completers; R0013210:Results

Weight loss of 5 percent or more (6 lines; O11A)

Week	Arm	Statistic	Estimate	Events / N	Detail
19.57	A1	responders		0 / 6	not stated; completers; R0013210:Results
19.57	A2	responders	83.3	10	not stated; completers; R0013210:Figure 2
19.57	A3	responders	91.7	11	not stated; completers; R0013210:Figure 2
27	A1	responders	0.0	6	not stated; completers; R0013210:Figure 2
27	A2	responders	58.3	10	not stated; completers; R0013210:Figure 2
27	A3	responders	91.7	11	not stated; completers; R0013210:Figure 2

Weight loss of 10 percent or more (6 lines; O11B)

Week	Arm	Statistic	Estimate	Events / N	Detail
19.57	A1	responders		0 / 6	not stated; completers; R0013210:Results
19.57	A2	responders	66.7	10	not stated; completers; R0013210:Figure 2
19.57	A3	responders	91.7	11	not stated; completers; R0013210:Figure 2
27	A1	responders	0.0	6	not stated; completers; R0013210:Figure 2
27	A2	responders	58.3	10	not stated; completers; R0013210:Figure 2
27	A3	responders	66.7	11	not stated; completers; R0013210:Figure 2

Weight loss of 15 percent or more (6 lines; O11C)

Week	Arm	Statistic	Estimate	Events / N	Detail
19.57	A1	responders		0 / 6	not stated; completers; R0013210:Results
19.57	A2	responders	66.7	10	not stated; completers; R0013210:Figure 2
19.57	A3	responders	75.0	11	not stated; completers; R0013210:Figure 2
27	A1	responders	0.0	6	not stated; completers; R0013210:Figure 2
27	A2	responders	41.7	10	not stated; completers; R0013210:Figure 2
27	A3	responders	41.7	11	not stated; completers; R0013210:Figure 2

Acute kidney injury (3 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

Three point MACE (3 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Results
A2	events	0 / 12	not stated; safety; R0013210:Results
A3	events	0 / 12	not stated; safety; R0013210:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Results
A2	events	2 / 12	not stated; safety; R0013210:Results
A3	events	1 / 12	not stated; safety; R0013210:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	11 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	8 / 12	not stated; safety; R0013210:Supplement Table S2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	7 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	6 / 12	not stated; safety; R0013210:Supplement Table S2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	7 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	5 / 12	not stated; safety; R0013210:Supplement Table S2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	1 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	2 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	4 / 12	not stated; safety; R0013210:Supplement Table S2

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Results
A2	events	2 / 12	not stated; safety; R0013210:Results
A3	events	1 / 12	not stated; safety; R0013210:Results

Gallbladder and biliary disease (3 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2

Suicidal ideation or behavior (3 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; safety; R0013210:Supplement Table S2
A2	events	0 / 12	not stated; safety; R0013210:Supplement Table S2
A3	events	0 / 12	not stated; safety; R0013210:Supplement Table S2