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A Study of LY3305677 in Participants With Obesity Or Overweight

A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05623839
Enrollment
32
Registered
2022-11-21
Start date
2022-11-16
Completion date
2023-06-27
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Brief summary

The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to 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. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.

Interventions

Administered SC

DRUGPlacebo

Administered SC

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants who are overtly healthy as determined by medical evaluation * Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)

Exclusion criteria

* Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma

Design outcomes

Primary

MeasureTime frameDescription
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 AdministrationBaseline through Week 20A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary

MeasureTime frameDescription
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677Predose up to 72 hours postdosePK: Cmax of LY3305677
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677Predose up to 72 hours postdosePK: AUC of LY3305677
Pharmacodynamics (PD): Percentage change in Body WeightBaseline through Week 20PD: Percentage change in Body Weight

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026