A Study of LY3502970 in Participants With Type 2 Diabetes... | NCT05048719

NCT05048719

ID	Type	Description	Link
J2A-MC-GZGE	Other Identifier	Eli Lilly and Company
2021-002806-29	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3 milligrams (mg) LY3502970	Experimental	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).	Drug: LY3502970
12 mg LY3502970	Experimental	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.	Drug: LY3502970
24 mg LY3502970	Experimental	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.	Drug: LY3502970
36 mg LY3502970 - 1	Experimental	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.	Drug: LY3502970
36 mg LY3502970 - 2	Experimental	Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Name	Type	Description	Arm Group Labels	Other Names
LY3502970	Drug	Administered orally	12 mg LY3502970 24 mg LY3502970 3 milligrams (mg) LY3502970 36 mg LY3502970 - 1 36 mg LY3502970 - 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c in LY3502970 as Compared to Placebo	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.	Baseline, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Anaheim Clinical Trials, LLC		Anaheim	California	92801	United States
Velocity Clinical Research, Huntington Park

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40481478	Derived	Wharton S, Rosenstock J, Konige M, Lin Y, Duffin K, Wilson J, Banerjee H, Pirro V, Kazda C, Mather K. Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x.
37369232

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received matching placebo.
FG001	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 27, 2021	Sep 6, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

All randomized participants who received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received matching placebo.
BG001	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.
BG002	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
BG003	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
BG004	36 mg LY3502970 - 1	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
BG005	36 mg LY3502970 - 2	Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
BG006	45 mg LY3502970 - 1	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
BG007	45 mg LY3502970 - 2	Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
BG008	1.5 mg Dulaglutide	Participants received 1.5 mg Dulaglutide administered SC QW.
BG009	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.30± 9.52 BG00159.00± 9.43 BG00257.40± 9.23 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00125 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00014 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Hungary

Title	Measurements
	BG00010 BG0018 BG002

Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Mean

Standard Deviation

Percentage of HbA1c

Title

Denominators

Categories

Title	Measurements
	BG0008.1± 0.9 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

All participants who received at least one dose of LY3502970 or placebo and had baseline and at least one post-baseline value for HbA1c.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 26

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
OG003	36 mg LY3502970	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.
OG004	45 mg LY3502970	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally QD.
OG005	Placebo	Participants received matching placebo.

Units	Counts
Participants	OG00046 OG00149 OG00242 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.19± 0.137 OG001-1.91± 0.133 OG002-1.79± 0.149 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG005		Mixed Models Analysis		<0.001		LS Mean Difference	-0.77			2-Sided	95	-1.13	-0.40					Superiority
OG001 OG005		Mixed Models Analysis		<0.001

Secondary

Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide

All participants who received at least one dose of LY3502970 or dulaglutide, had a baseline, and at least one post-baseline value for HbA1c.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 26

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Secondary

Percentage of Participants With HbA1c ≤ 6.5%

Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.

All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
OG003	36 mg LY3502970	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.

Secondary

Percentage of Participants With HbA1c <7.0%

Percentage of Participants with HbA1c <7.0%. Odds ratio was calculated using logistic regression model.

All participants who received at least one dose of study drug, had a baseline and at least one post-baseline HbA1c value.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
OG003	36 mg LY3502970	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.

Secondary

Change From Baseline in Fasting Serum Glucose

Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, 8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

All participants who received at least one dose of study drug, had baseline and at least one post-baseline fasting glucose data.

Posted

Least Squares Mean

Standard Error

milligrams per deciliter (mg/dL)

Baseline, Week 26

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
OG003

Secondary

Change From Baseline in Body Weight

LS mean was determined by MMRM model with Baseline + Country + Baseline HbA1c Group (<=8.0%, >8.0%) + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

All participants who received at least one dose of study drug, had baseline and at least one post-baseline body weight data.

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, Week 26

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily QD.
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
OG003	36 mg LY3502970

Secondary

Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970

PK: Steady State AUC of LY3502970

All participants who received at least one dose of LY3502970 and had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram *hour per milliliter (ng*h/mL)

Pre-dose (Week (wk) 0, wk 8, wk 12, and wk 26); Post-dose (wk 4, wk 8, wk 16, wk 20, and end of treatment).

ID	Title	Description
OG000	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.
OG001	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
OG002	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
OG003	36 mg LY3502970 - 1

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received matching placebo.	1	55	3	55	25	55
EG001	3 mg LY3502970	Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally QD.	0	51	3	51	34	51
EG002	12 mg LY3502970	Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.	0	56	1	56	40	56
EG003	24 mg LY3502970	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.	0	47	5	47	32	47
EG004	36 mg LY3502970 - 1	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.	0	27	1	27	21	27
EG005	36 mg LY3502970 - 2	Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.	0	34	1	34	18	34
EG006	45 mg LY3502970 - 1	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.	0	31	0	31	21	31
EG007	45 mg LY3502970 - 2	Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.	0	32	1	32	23	32
EG008	1.5 mg Dulaglutide	Participants received 1.5 mg Dulaglutide administered SC QW.	0	50	1	50	23	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected51 at risk EG0020 events0 affected56 at risk EG0030 events0 affected47 at risk EG0040 events0 affected27 at risk EG0050 events0 affected34 at risk EG0060 events0 affected31 at risk EG0070 events0 affected32 at risk EG0080 events0 affected50 at risk
Cardiac failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Pylorospasm	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected51 at risk EG0020 events0 affected56 at risk EG003
Appendicitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0021 events1 affected56 at risk EG003
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected51 at risk EG0020 events0 affected56 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Urethral haemorrhage	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected51 at risk EG0023 events3 affected56 at risk EG0030 events0 affected47 at risk EG0041 events1 affected27 at risk EG0050 events0 affected34 at risk EG0060 events0 affected31 at risk EG0071 events1 affected32 at risk EG0081 events1 affected50 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected51 at risk EG0020 events0 affected56 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0012 events2 affected51 at risk EG0023 events3 affected56 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0015 events3 affected51 at risk EG0022 events1 affected56 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0019 events7 affected51 at risk EG0028 events7 affected56 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0006 events4 affected55 at risk EG00118 events11 affected51 at risk EG00210 events9 affected56 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0016 events6 affected51 at risk EG0024 events4 affected56 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0014 events4 affected51 at risk EG0023 events2 affected56 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0024 events4 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected55 at risk EG00115 events12 affected51 at risk EG00227 events21 affected56 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0013 events3 affected51 at risk EG00216 events12 affected56 at risk EG003
Asthenia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0013 events3 affected51 at risk EG0025 events5 affected56 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected25 at risk EG0020 events0 affected20 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected55 at risk EG0012 events2 affected51 at risk EG0025 events5 affected56 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected55 at risk EG0012 events2 affected51 at risk EG0021 events1 affected56 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected51 at risk EG0020 events0 affected56 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Lipase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected55 at risk EG0012 events2 affected51 at risk EG0025 events5 affected56 at risk EG003
Weight decreased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0022 events2 affected56 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0013 events3 affected51 at risk EG0024 events3 affected56 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected55 at risk EG0011 events1 affected51 at risk EG0020 events0 affected56 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0022 events2 affected56 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected51 at risk EG0020 events0 affected56 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected51 at risk EG0021 events1 affected56 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0014 events4 affected51 at risk EG0021 events1 affected56 at risk EG003
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0019 events7 affected51 at risk EG0022 events2 affected56 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected51 at risk EG0020 events0 affected56 at risk EG003
Epididymal cyst	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected26 at risk EG0020 events0 affected36 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected51 at risk EG0023 events2 affected56 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected55 at risk EG0013 events3 affected51 at risk EG0021 events1 affected56 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C000729680	orforglipron
C555680	dulaglutide

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally QD.

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

EG0040 events0 affected27 at risk

EG0050 events0 affected34 at risk