DyslipidemiasPhase 1NCT02714569

A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

A Phase 1 study testing LY3202328, Atorvastatin and Simvastatin in people with Dyslipidemias, run by Eli Lilly and Company at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this two-part study is to evaluate the safety and tolerability of the study drug known as LY3202328 in healthy overweight participants in Part A, and those with dyslipidemia (abnormal blood fats) in Part B. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Dyslipidemias
What is being tested?: LY3202328, Atorvastatin and Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 4 sitesUnited States
Study dates: Mar 2016to 15 Feb 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be healthy, as determined by medical history and physical examination
Male participants must be between 18 and 70 years of age and must agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
Female participants must be between 40 and 70 years old, and either postmenopausal or with a hysterectomy, and not pregnant and not lactating
Be on a stable diet and exercise regimen for greater than (>) 3 months prior
Have a body mass index (BMI) of 25.0 to 35.0 (Part A) or 27.0 to 40.0 (Part B) kilograms per meter squared
Have fasting triglycerides (TG) between 150 and 499 milligrams per deciliter (mg/dL) (Part B only)

Show all 9Show fewer

Have a fasting low-density lipoprotein cholesterol (LDL-c) between 100 and 200 mg/dL (Part B only)
Have estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute/1.73 meter squared with no proteinuria
Be normotensive defined as supine systolic blood pressure (BP) less than or equal to (≤) 150 millimeters of mercury (mm Hg) and diastolic BP ≤ 100 mm Hg, without the use of any antihypertensive

Who cannot join

Are taking a statin, any proprotein convertase subtilisin/kexin type 9 (PCSK9) medications, or have started taking other TG lowering agents (for example, niacin, fish oils)
Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research, or have participated in a clinical trial involving an investigational product or non-approved use of a drug within the last 30 days or within 5 half-lives
Have an abnormal electrocardiogram or corrected QT or are on antihypertensive treatment
Have any current or prior history of significant cardiovascular disease
Show evidence of hepatitis C virus (HCV), Hepatitis B or other chronic liver disease
Have an alcohol intake that exceeds 7 units per week with no more than 3 units per day, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces or 360 mL of beer; 5 ounces or 150 mL of wine; 1.5 ounces or 45 mL of distilled spirits), or are a regular user of known drugs of abuse

Show all 13Show fewer

Have a history of untreated endocrine illness such as diabetes mellitus
Have been on medications or supplements for weight loss within 3 months
Have a history of active neuropsychiatric disease or on pharmacological therapy for such conditions (Part B, only)
Show evidence of human immunodeficiency virus (HIV) infection
Have been on medications that are known to inhibit cytochrome P450, family 3, subfamily A (CYP3A) or P-glycoprotein (P-gp), or regularly consume grapefruit
Have donated blood of more than 500 mL within the last month
Smoke >10 cigarettes per day or are unwilling to follow smoking rules

Trial locations and contacts

4 sites in 1 country.

United States4 sites

PRA Health Sciences
Lenexa, Kansas, 06219
PRA Health Sciences
Marlton, New Jersey, 08053
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014
PRA Health Sciences
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328

Conditions: Dyslipidemias
Being tested: LY3202328, Placebo, Atorvastatin, Simvastatin
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3202328Drug
Administered orally
PlaceboDrug
Administered orally
AtorvastatinDrug
Administered orally
SimvastatinDrug
Administered orally

Study groups in NCT02714569
Study group	Role	What they receive
Part A: LY3202328 (LY)	Experimental	Single ascending doses of 1 milligram (mg), 3 mg, 10 mg, 30 mg, 100 mg, 300mg, 600 mg LY3202328 orally while fasting, or 30 mg LY3202328 orally while fed in 4 periods. Receives: Drug: LY3202328
Part A: Placebo	Placebo comparator	A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed. Receives: Drug: Placebo
Part B: LY3202328 (LY)	Experimental	A multiple ascending dose of 5 mg, 20 mg, 100 mg, and 300 mg LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29. Receives: Drug: LY3202328; Drug: Atorvastatin; Drug: Simvastatin
Part B: Placebo	Placebo comparator	A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29. Receives: Drug: Placebo; Drug: Atorvastatin; Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B
Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Measured: Baseline, Up to 42 Days

Secondary outcomes (18)

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose
Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B
PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.
Measured: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose
PK is the area under the serum concentration time curve from zero to Infinity (AUC[0-∞]) of LY3202328 in Part A after a single dose.
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B
PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B.
Measured: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A
PK is the time to maximum concentration (Tmax) of LY3202328 in Part A
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK: Steady State Tmax of LY3202328 (LY) in Part B
PK is the Tmax of LY3202328 at steady state in Part B.
Measured: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A
Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.
Measured: Predose, 24, 48, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B
PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.
Measured: Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline in Fasting Total Triglycerides Part A
PD is the change from baseline in fasting total triglycerides in Part A.
Measured: Predose, 24, 48, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B
PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B.
Measured: Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline to in Fasting Total Cholesterol in Part A
PD is the change from baseline in fasting total cholesterol in Part A.
Measured: Predose, 24, 28, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B
PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.
Measured: Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A
PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.
Measured: Predose, 24, 48, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B
PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.
Measured: Predose, Days 7, 14, 21, and 28 Postdose
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.
Measured: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.
Measured: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.
Measured: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.
Measured: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201615 Feb 2017

First posted21 Mar 2016 (estimated)
Study startMar 2016
Primary completion15 Feb 2017
Study completion15 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiasStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Part A is a crossover. Part B is a parallel assignment.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02714569
Sponsor's protocol ID: 16417
Other IDs: I8Q-MC-GSEA
Status last verified: May 2021
First submitted: 16 Mar 2016
Last updated: 25 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328
ClinicalTrials.gov ID: NCT02714569
Acronym / sponsor ID: 16417
Conditions: Dyslipidemias
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: 15 Feb 2017 (actual)
Study completion: 15 Feb 2017 (actual)
First posted: 21 Mar 2016 (estimated)
Results: Posted 25 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Part A is a crossover. Part B is a parallel assignment.

Arm	Type	Receives
Part A: LY3202328 (LY)	Experimental	Drug: LY3202328Single ascending doses of 1 milligram (mg), 3 mg, 10 mg, 30 mg, 100 mg, 300mg, 600 mg LY3202328 orally while fasting, or 30 mg LY3202328 orally while fed in 4 periods.
Part A: Placebo	Placebo comparator	Drug: PlaceboA single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.
Part B: LY3202328 (LY)	Experimental	Drug: LY3202328, Drug: Atorvastatin, Drug: SimvastatinA multiple ascending dose of 5 mg, 20 mg, 100 mg, and 300 mg LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.
Part B: Placebo	Placebo comparator	Drug: Placebo, Drug: Atorvastatin, Drug: SimvastatinA multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Be healthy, as determined by medical history and physical examination
Male participants must be between 18 and 70 years of age and must agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
Female participants must be between 40 and 70 years old, and either postmenopausal or with a hysterectomy, and not pregnant and not lactating
Be on a stable diet and exercise regimen for greater than (>) 3 months prior
Have a body mass index (BMI) of 25.0 to 35.0 (Part A) or 27.0 to 40.0 (Part B) kilograms per meter squared

Key exclusion criteria (13 listed)

Are taking a statin, any proprotein convertase subtilisin/kexin type 9 (PCSK9) medications, or have started taking other TG lowering agents (for example, niacin, fish oils)
Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research, or have participated in a clinical trial involving an investigational product or non-approved use of a drug within the last 30 days or within 5 half-lives
Have an abnormal electrocardiogram or corrected QT or are on antihypertensive treatment
Have any current or prior history of significant cardiovascular disease
Show evidence of hepatitis C virus (HCV), Hepatitis B or other chronic liver disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3202328Administered orally	Drug	Part A: LY3202328 (LY), Part B: LY3202328 (LY)
PlaceboAdministered orally	Drug	Part A: Placebo, Part B: Placebo
AtorvastatinAdministered orally	Drug	Part B: LY3202328 (LY), Part B: Placebo
SimvastatinAdministered orally	Drug	Part B: LY3202328 (LY), Part B: Placebo

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B
Time frame: Baseline, Up to 42 Days
Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

18 secondary outcomes

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK: Steady State Tmax of LY3202328 (LY) in Part B
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A
Time frame: Predose, 24, 48, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline in Fasting Total Triglycerides Part A
Time frame: Predose, 24, 48, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline to in Fasting Total Cholesterol in Part A
Time frame: Predose, 24, 28, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A
Time frame: Predose, 24, 48, 96 Hours Postdose
PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

Results and safety

Results posted to the registry on 25 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Cohort 1(C1), Sequence 1	3	3
Part A: C1, Sequence 2	3	3
Part A: C1, Sequence 3	3	3
Part A: Cohort 2 (C2), Sequence 1	3	3
Part A: C2, Sequence 2	3	3
Part A: C2, Sequence 3	3	3
Part B: C3 (Simvastatin [SS]/Atorvastatin[AS] + 5 mg LY)	0	0
Part B: C4 (SS/AS + 20 mg LY)	0	0
Part B: C5 (SS/AS + 100 mg LY)	0	0
Part B: C6 (SS/AS + 300 mg LY)	0	0
Part B: C3-C6 (SS/AS + Placebo)	0	0

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B

Time frame: Baseline, Up to 42 Days. Number. Unit: participants

Measure	Part A: Placebo n = 20	Part A: 1 mg LY3202328 (LY) n = 7	Part A: 3 mg LY n = 6	Part A: 10 mg LY n = 8	Part A: 30 mg LY n = 6	Part A: 100 mg LY n = 7	Part A: 300 mg LY n = 6	Part A: 30 mg LY Fed n = 7	Part A: 600 mg LY n = 7	Part B: SS/AS/Placebo n = 8	Part B: SS/AS/5 mg of LY n = 8	Part B: SS/AS/20 mg of LY n = 8	Part B: SS/AS/100 mg of LY n = 8	Part B: SS/AS/300 mg of LY n = 8
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Population analysed: All participants who received at least one dose of study drug.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to End of Study (Up to 10 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 25 (0%)	2 of 25 (8%)	0 of 25
1 mg LY3202328 (LY)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
3 mg LY	0 of 6 (0%)	0 of 6 (0%)	0 of 6
5 mg LY	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
10 mg LY	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
20 mg LY	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
30 mg LY	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
30 mg LY Fed	0 of 4 (0%)	0 of 4 (0%)	0 of 4
100 mg LY	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
300 mg LY	2 of 14 (14.3%)	6 of 14 (42.9%)	0 of 14
600 mg of LY	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of LY3202328 in Overweight Healthy Participants and in Participants With DyslipidemiaLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3202328, Atorvastatin and Simvastatin in people with Dyslipidemias, run by Eli Lilly and Company at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B (time frame: Baseline, Up to 42 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.