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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of LY3502970 in Healthy Overweight and Obese Participants

NCTNCT05313802 (opens ClinicalTrials.gov in a new tab)Other id18453Other idJ2A-MC-GZGK
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
72 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
26 May 2022
Primary completion
9 Sept 2022
Completion
9 Sept 2022
First posted
6 Apr 2022
Last update posted
26 May 2026
Conditions
Healthy · Obese

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023
  1. Ph 1

    A Study of LY3502970 in Healthy Overweight and Obese Participants

    NCT05313802

    26 May 2022 to 9 Sept 2022

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 the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.

Interventions

  • LY3502970Drug

Arms3

  • Experimental

    LY3502970 Cohort 1

    Participants received oral doses of 2 milligrams (mg) LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 once daily (QD).

  • Experimental

    LY3502970 Cohort 2

    Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD.

  • Experimental

    LY3502970 Cohort 3

    Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame · Baseline up to Day 42

    Registry description

    A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.

Secondary outcomes(7)

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1

    Time frame · Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    Registry description

    PK: AUC\[0-tlast\] of LY3502970

  2. PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1

    Time frame · Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    Registry description

    PK: Cmax of LY3502970

  3. PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1

    Time frame · Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    Registry description

    PK: Tmax of LY3502970

  4. PK: AUC[0-tlast] of LY3502970 on Day 28

    Time frame · Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    Registry description

    PK: AUC\[0-tlast\] of LY3502970

  5. PK: Cmax of LY3502970 on Day 28

    Time frame · Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    Registry description

    PK: Cmax of LY3502970

  6. PK: Tmax of LY3502970 on Day 28

    Time frame · Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

    Registry description

    PK: Tmax of LY3502970

  7. Pharmacodynamics (PD): Change From Baseline in Body Weight

    Time frame · Baseline through Day 29

    Registry description

    PD: Change From Baseline in Body Weight

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 outcomeNumber· Baseline up to Day 42

Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

GroupValue (participants)
LY3502970 Cohort 120
LY3502970 Cohort 221
LY3502970 Cohort 316
Secondary and other outcome results(7)
Secondary outcomeGeometric mean· Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1

GroupValue (nanogram hour per milliliter (ng*h/mL))Spread
LY3502970 Cohort 111739
LY3502970 Cohort 266.125
LY3502970 Cohort 366.930
Secondary outcomeGeometric mean· Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1

GroupValue (nanograms per milliliter (ng/mL))Spread
LY3502970 Cohort 18.4041
LY3502970 Cohort 24.9725
LY3502970 Cohort 35.0034
Secondary outcomeMedian· Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1

GroupValue (hours (h))
LY3502970 Cohort 17.03
LY3502970 Cohort 26.00
LY3502970 Cohort 36.00
Secondary outcomeGeometric mean· Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

PK: AUC[0-tlast] of LY3502970 on Day 28

GroupValue (ng*h/mL)Spread
LY3502970 Cohort 127540
LY3502970 Cohort 227734
LY3502970 Cohort 331426
Secondary outcomeGeometric mean· Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

PK: Cmax of LY3502970 on Day 28

GroupValue (ng/mL)Spread
LY3502970 Cohort 118.443
LY3502970 Cohort 218.441
LY3502970 Cohort 321.235
Secondary outcomeMedian· Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

PK: Tmax of LY3502970 on Day 28

GroupValue (h)
LY3502970 Cohort 16.00
LY3502970 Cohort 26.00
LY3502970 Cohort 36.00
Secondary outcomeMean· Baseline through Day 29

Pharmacodynamics (PD): Change From Baseline in Body Weight

GroupValue (kilograms (kg))Spread
LY3502970 Cohort 1-4.22.5
LY3502970 Cohort 2-5.53.5
LY3502970 Cohort 3-3.61.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LY3502970 Cohort 1Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.0 / 240 / 2419 / 24
LY3502970 Cohort 2Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD.0 / 240 / 2420 / 24
LY3502970 Cohort 3Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD.0 / 240 / 2413 / 24

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: * Participants with stable body weight for at least one month prior to randomization. * Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²) * Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Exclusion Criteria: * Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs * Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders * Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %

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