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Monoclonal Antibodies
LY3437943 for Diabetes
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 106
Awards & highlights
All Individual Drugs Already Approved
Summary
The main purpose of this study is to learn about the side effects of LY3437943 when given to participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.
Eligible Conditions
- Diabetes
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 106
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 106
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary study objectives
Change from Baseline in Mean Daily Plasma Glucose (PG)
PK: Maximum Concentration (Cmax) of LY3437943
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943
Side effects data
From 2022 Phase 2 trial • 281 Patients • NCT0486778520%
Decreased appetite
20%
Nausea
15%
Diarrhoea
11%
Constipation
11%
Vomiting
11%
Upper respiratory tract infection
11%
Urinary tract infection
7%
Fatigue
7%
Dyspepsia
4%
Anaemia
4%
Covid-19
4%
Lipase increased
4%
Dizziness
4%
Weight decreased
2%
Cellulitis
2%
Diabetic ketoacidosis
2%
Abdominal pain
2%
Eructation
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mg LY3437943 (2 mg)
8 mg LY3437943 (2 mg)
Placebo
1.5 Milligram (mg) Dulaglutide
0.5 mg LY3437943
4 mg LY3437943 (2 mg)
4 mg LY3437943 (4 mg)
8 mg LY3437943 (4 mg)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LY3437943Experimental Treatment1 Intervention
LY3437943 administered subcutaneously (SC)
Group II: DulaglutideActive Control1 Intervention
Dulaglutide administered SC
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3437943
2022
Completed Phase 2
~1090
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,672 Previous Clinical Trials
3,463,721 Total Patients Enrolled
11 Trials studying Diabetes
15,619 Patients Enrolled for Diabetes
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,626 Total Patients Enrolled
3 Trials studying Diabetes
4,328 Patients Enrolled for Diabetes
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