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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

NCTNCT05841238 (opens ClinicalTrials.gov in a new tab)Other id18527Other idJ2A-MC-GZGN
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
52 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
26 Apr 2023
Primary completion
14 Sept 2023
Completion
13 Nov 2023
First posted
3 May 2023
Last update posted
10 Jul 2026
Conditions
Healthy · Obese

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 1

    A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

    NCT05841238

    26 Apr 2023 to 13 Nov 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.

Interventions

  • LY3502970Drug

Arms4

  • Experimental

    Part A: LY3502970 (Periods 1 to 11)

    Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows: * Period 1 (Day 1-7): 0.8 milligram (mg) LY3502970 tablet (fasted state) * Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state) * Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state) * Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state) * Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state) * Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state) * Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state) * Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state) * Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state) * Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state) * Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state)

  • Experimental

    Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13)

    Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state)

  • Experimental

    Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13)

    Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state)

  • Experimental

    Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13)

    Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 36 mg LY3502970 dual-fill (DF) capsule (fasted state) * Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state)

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Time frame · Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Registry description

    PK: AUC\[0-24\] of LY3502970 in fasted state

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Time frame · Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Registry description

    PK: Cmax of LY3502970 in fasted state

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Time frame · Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

    Registry description

    PK: Tmax of LY3502970 in fasted state

Secondary outcomes(3)

  1. PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10

    Time frame · Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

    Registry description

    PK: AUC\[0-24\] of LY3502970 in fed state

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10

    Time frame · Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

    Registry description

    PK: Cmax of LY3502970 in fed state

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10

    Time frame · Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

    Registry description

    PK: Tmax of LY3502970 in fed state

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

GroupValue (nanogram*hour per milliliter (ng*h/mL))Spread
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)90.827
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)19934
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)29431
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)54829
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)70042
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)108032
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)125040
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)197048
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)158072
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)368047
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)373037
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)408040
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)410051
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)641049
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)195059
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)303045
Primary outcomeGeometric mean· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

GroupValue (nanograms per milliliter (ng/mL))Spread
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)6.0826
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)13.539
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)19.934
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)36.635
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)45.149
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)69.834
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)73.558
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)12657
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)10089
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)25754
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)23439
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)29539
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)27549
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)46055
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)10958
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)20348
Primary outcomeMedian· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13

GroupValue (hours)
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)6.00
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)6.00
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)6.00
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)6.00
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)8.00
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)6.00
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)6.00
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)8.00
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)8.00
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)6.03
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)8.00
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)4.03
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)4.07
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)8.00
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)5.92
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)6.88
Secondary and other outcome results(3)
Secondary outcomeGeometric mean· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10

GroupValue (nanogram*hour per milliliter (ng*h/mL))Spread
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)1230139
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)317036
Secondary outcomeGeometric mean· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10

GroupValue (nanograms per milliliter (ng/mL))Spread
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)81.0104
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)20351
Secondary outcomeMedian· Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10

GroupValue (hours)
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)12.00
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)6.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State)Participants who received a QD oral dose of 0.8 mg LY3502970 tablet in fasted state from Day 1 to Day 7 are grouped under this arm.0 / 520 / 527 / 52
Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State)Participants who received a QD oral dose of 2 mg LY3502970 capsule in fasted state from Day 8 to Day 14 are grouped under this arm.0 / 500 / 506 / 50
Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State)Participants who received a QD oral dose of 2.5 mg LY3502970 tablet in fasted state from Day 15 to Day 21 are grouped under this arm.0 / 500 / 503 / 50
Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State)Participants who received a QD oral dose of 5 mg LY3502970 tablet in fasted state from Day 22 to Day 28 are grouped under this arm.0 / 500 / 508 / 50
Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State)Participants who received a QD oral dose of 8 mg LY3502970 capsule in fasted state from Day 29 to Day 35 are grouped under this arm.0 / 490 / 4913 / 49
Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State)Participants who received a QD oral dose of 10 mg LY3502970 tablet in fasted state from Day 36 to Day 42 are grouped under this arm.0 / 490 / 499 / 49
Part A: Period 7 (Day 43-49): 16 mg LY3502970 Capsule (Fasted State)Participants who received a QD oral dose of 16 mg LY3502970 capsule in fasted state from Day 43 to Day 49 are grouped under this arm.0 / 460 / 464 / 46
Part A: Period 8 (Day 50-56): 20 mg LY3502970 Tablet (Fasted State)Participants who received a QD oral dose of 20 mg LY3502970 tablet in fasted state from Day 50 to Day 56 are grouped under this arm.0 / 461 / 464 / 46
Part A: Period 9 (Day 57-63): 36 mg LY3502970 Capsule (Fasted State)Participants who received a QD oral dose of 36 mg LY3502970 capsule in fasted state from Day 57 to Day 63 are grouped under this arm.0 / 451 / 452 / 45
Part A: Period 10 (Day 64-70): 36 mg LY3502970 Capsule (Fed State)Participants who received a QD oral dose of 36 mg LY3502970 capsule in fed state from Day 64 to Day 70 are grouped under this arm.0 / 210 / 213 / 21
Part A: Period 10 (Day 64-70): 37.5 mg LY3502970 Tablet (Fed State)Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fed state from Day 64 to Day 70 are grouped under this arm.0 / 210 / 2112 / 21
Part A: Period 11 (Day 71-77): 37.5 mg LY3502970 Tablet (Fasted State)Participants who received a QD oral dose of 37.5 mg LY3502970 tablet in fasted state from Day 71 to Day 77 are grouped under this arm.0 / 410 / 4112 / 41
Part B: Period 12 (Day 78-84): 35 mg LY3502970 Tablet (Fasted State)Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.0 / 70 / 73 / 7
Part B: Period 13 (Day 85-91): 35 mg LY3502970 Tablet (Fasted State)Participants who completed Part A and received a QD oral dose of 35 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.0 / 70 / 71 / 7
Part B: Period 12 (Day 78-84): 45 mg LY3502970 Tablet (Fasted State)Participants who completed Part A and received a QD oral dose of 45 mg LY3502970 tablet in fasted state from Day 78 to Day 84 are grouped under this arm.0 / 210 / 214 / 21
Part B: Period 13 (Day 85-91): 60 mg LY3502970 Tablet (Fasted State)Participants who completed Part A and received a QD oral dose of 60 mg LY3502970 tablet in fasted state from Day 85 to Day 91 are grouped under this arm.0 / 210 / 215 / 21
Part B: Period 12 (Day 78-84): 36 mg LY3502970 DF Capsule (Fasted State)Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 DF capsule in fasted state from Day 78 to Day 84 are grouped under this arm.0 / 120 / 123 / 12
Part B: Period 13 (Day 85-91): 36 mg LY3502970 EPB Capsule (Fasted State)Participants who completed Part A and received a QD oral dose of 36 mg LY3502970 EPB capsule in fasted state from Day 85 to Day 91 are grouped under this arm.0 / 120 / 126 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female participants who are overtly healthy as determined by medical evaluation * Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more * Participants with a stable body weight, with 5% or less body weight gain or loss Exclusion Criteria: * Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL) * Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome * Have known clinically significant gastric emptying abnormality * Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass) * Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer * Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug * Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years

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