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Trial · Interventional

CompletedPhase 1Registry data

A Study of LY3305677 in Participants With Obesity Or Overweight

NCTNCT05623839 (opens ClinicalTrials.gov in a new tab)Other id18522Other idI8P-MC-OXAG
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
16 Nov 2022
Primary completion
27 Jun 2023
Completion
27 Jun 2023
First posted
21 Nov 2022
Last update posted
5 Jul 2023
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 1

    A Study of LY3305677 in Participants With Obesity Or Overweight

    NCT05623839

    16 Nov 2022 to 27 Jun 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 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

  • LY3305677Drug
  • PlaceboDrug

Arms2

  • Experimental

    LY3305677

    LY3305677 administered subcutaneously (SC)

  • Placebo comparator

    Placebo

    Placebo administered SC

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 20

    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(3)

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677

    Time frame · Predose up to 72 hours postdose

    Registry description

    PK: Cmax of LY3305677

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677

    Time frame · Predose up to 72 hours postdose

    Registry description

    PK: AUC of LY3305677

  3. Pharmacodynamics (PD): Percentage change in Body Weight

    Time frame · Baseline through Week 20

    Registry description

    PD: Percentage change in Body Weight

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

10 results

Mazdutide reduces body weight in adults with overweight or obesity: A high-dose Phase 1 trial.

Bhattachar et al. 2025Diabetes, obesity & metabolismcited by 9

PMID 40832785PMC12515780DOI 10.1111/dom.70040PUB-40832785

Free to read · publisher termsCC BY-NC10 results
Read at sourceSee results (10)

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 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

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