A Study of LY4329090 in Participants With Obesity or Overweight Who Are Otherwise Healthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company
About this trial
The main purpose of this study is to assess how well LY4329090 is tolerated and what side effects may occur in healthy participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Study participants will be in one of 2 parts. For each participant in Part A, the study will last about 10 weeks and will include a stay in the Clinical Research Unit (CRU) lasting 5 nights along with 5 outpatient visits to the CRU. For each participant in Part B, the study will last about 21 weeks and will include 4 stays totaling 11 nights along with 14 outpatient visits to the CRU.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant must be 18 (21 for Singapore site) to 65 years of age, inclusive, at the time of signing the informed consent.
Are overtly healthy with no comorbidities related to body mass index (BMI).
Have a BMI between 27.0 kilograms per square meter (kg/m²) and 40.0 kg/m², inclusive.
Have had a self-reported stable weight for 3 months prior to screening.
Disqualifiers
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders.
Have a history of chronic medical conditions involving the heart, liver, or kidneys.
Have either
ongoing asymptomatic bradycardia defined as less than 50 beats per minute at screening visit
Trial design
Design model
Parallel
Treatments tested in this trial
LY4329090
DrugAdministered SC
Placebo
DrugAdministered SC
Treatment groups
184 Participants
are divided into 4 treatment groupsGroup A: LY4329090 Part AExperimental treatment 1 intervention
Group B: Placebo Part AExperimental treatment 1 intervention
Group C: LY4329090 Part BExperimental treatment 1 intervention
Group D: Placebo Part BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame
End of Study (Week 28)Secondary outcomes
1
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4329090
Time frame
Baseline through Week 282
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY4329090
Time frame
Baseline through Week 283
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4329090
Time frame
Baseline through Week 284
Pharmacodynamics (PD): Body Weight Change from Baseline
Time frame
Baseline through Week 28Sponsors and contacts
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Source ClinicalTrials.gov