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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities

NCTNCT06023095 (opens ClinicalTrials.gov in a new tab)Other id18610Other idJ2A-GH-GZGX
Open at ClinicalTrials.govAsk about this trial

Overview

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

China

Start
21 Sept 2023
Primary completion
29 Jul 2024
Completion
29 Jul 2024
First posted
5 Sept 2023
Last update posted
17 Jul 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 1

    A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities

    NCT06023095

    21 Sept 2023 to 29 Jul 2024

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 learn about the safety and tolerability of LY3502970 when given to Chinese participants with obesity or overweight with weight-related comorbidities. 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 LY3502970, or placebo given orally. For each participant, the study will last about approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening period.

Interventions

  • LY3502970Drug
  • PlaceboDrug

Arms3

  • Experimental

    LY3502970 (Cohort 1)

    Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 milligram (mg), 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily (QD) from Day 1 for 16 weeks.

  • Experimental

    LY3502970 (Cohort 2)

    Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.

  • Placebo comparator

    Placebo

    Participants received placebo administered orally 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 through Week 18 (Cohort 1) & Week 26 (Cohort 2)

    Registry description

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes(8)

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1)

    Time frame · Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)

    Registry description

    Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol.

  2. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)

    Time frame · Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)

    Registry description

    Pharmacokinetic parameter Cmax (maximum observed plasma concentration) of LY3502970 following multiple oral doses at escalating dose levels. Cmax was assessed at steady state using plasma concentration-time data collected at specified timepoints per protocol.

  3. PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 1)

    Time frame · Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)

    Registry description

    Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol.

  4. PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)

    Time frame · Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)

    Registry description

    Pharmacokinetic parameter AUC0-24 of LY3502970 following multiple oral doses at escalating dose levels. AUC0-24 was derived using plasma concentration-time data collected at predefined time points over a 24-hour dosing interval at steady state per protocol.

  5. PD: Change From Baseline in Body Mass Index

    Time frame · Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    Registry description

    PD: Change from baseline in Body Mass Index calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Body Mass Index.

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

    Time frame · Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    Registry description

    PD: Change from baseline in body weight calculated as post-baseline value minus baseline value. Negative values indicate a decrease in body weight.

  7. PD: Change From Baseline in Waist Circumference

    Time frame · Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    Registry description

    PD: Change from baseline in Waist Circumference calculated as post-baseline value minus baseline value. Negative values indicate a decrease in Waist Circumference.

  8. PD: Change From Baseline in Fasting Plasma Glucose

    Time frame · Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

    Registry description

    PD: Change From Baseline in Fasting Plasma Glucose calculated as post-baseline value minus baseline value. Negative values indicate a decrease from baseline

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 outcomeCount of participants· Baseline through Week 18 (Cohort 1) & Week 26 (Cohort 2)

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 1)10
LY3502970 (Cohort 2)8
Placebo3
Secondary and other outcome results(7)
Secondary outcomeGeometric mean· Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 1)

GroupValue (nanogram per millilitre (ng/mL))Spread
LY3502970 (Cohort 1)17.639
Secondary outcomeGeometric mean· Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 at Steady State (Cohort 2)

GroupValue (nanogram per millilitre (ng/mL))Spread
LY3502970 (Cohort 2)5.0144
Secondary outcomeGeometric mean· Cohort 1: Day 56 and Day 112 (Predose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post dose)

PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 1)

GroupValue (nanogram *hour per milliliter (ng*h/mL))Spread
LY3502970 (Cohort 1)26626
Secondary outcomeGeometric mean· Day 28, Day 84, Day 140, and Day 168 (Predose, 0.5, 1, 2, 4, 6, 12, and 24 hours post dose)

PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hour Time Point (AUC0-24) of LY3502970 at Steady State (Cohort 2)

GroupValue (nanogram *hour per milliliter (ng*h/mL))Spread
LY3502970 (Cohort 2)80.442
Secondary outcomeMean· Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

PD: Change From Baseline in Body Mass Index

GroupValue (kilograms per square meter (kg/m²))Spread
LY3502970 (Cohort 1)-2.30461.1819
LY3502970 (Cohort 2)-3.59641.4441
Placebo (Cohort 1)NANA
Placebo (Cohort 2)NANA
Secondary outcomeMean· Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

Pharmacodynamics (PD): Change From Baseline in Body Weight

GroupValue (kilograms (kg))Spread
LY3502970 (Cohort 1)-6.1563.710
LY3502970 (Cohort 2)-10.2114.011
Placebo (Cohort 1)NANA
Placebo (Cohort 2)NANA
Secondary outcomeMean· Baseline through 113 Days (Cohort 1) and 169 Days (Cohort 2)

PD: Change From Baseline in Waist Circumference

GroupValue (centimeters (cm))Spread
LY3502970 (Cohort 1)-5.7782.879
LY3502970 (Cohort 2)-11.6673.466
Placebo (Cohort 1)NANA
Placebo (Cohort 2)NANA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LY3502970 (Cohort 1)Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg and then 12 mg LY3502970 administered orally QD from Day 1 for 16 weeks.0 / 100 / 1010 / 10
LY3502970 (Cohort 2)Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks.0 / 100 / 1010 / 10
PlaceboParticipants received placebo administered orally QD.0 / 40 / 43 / 4

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 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Are native Chinese males or females * Have had a stable body weight for the 3 months prior to randomization (less than 5% body weight change) and body mass index of ≥ 30.0 kilograms per square meter (kg/m²) or between 27.0 up to 30.0 kg/m² with at least 1 of the following weight-related comorbidities including Hypertension, Dyslipidemia, Cardiovascular disease, Obstructive sleep apnea Exclusion Criteria: * Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus * Have used or intend to use any prescription or over-the-counter medications or traditional Chinese treatments within 3 months prior to screening, exception of medications for the treatment of concurrent medical conditions with a stable dose * Have known allergies to GLP-1RAs, LY3502970, related compounds, any components of the formulation, or have a history of significant atopy * Are overweight or have obesity induced by other endocrinological disorders, diagnosed monogenetic, or syndromic forms of obesity * Have or plan to have a surgical, endoscopic or device-based treatment for obesity * Have a history or presence of psychiatric disorder, a moderately severe or severe depression status, or a significantly risk for suicide * Have a history of acute or chronic pancreatitis * Have a known self or family history of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma * Have other acute, chronic, or uncontrolled medical conditions, vital organ failure or abnormal laboratory value in the judgment of the investigator would make the participant inappropriate for entry into this study

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