A Study of LY3305677 in Participants With Obesity Or Overweight

NCT ID: NCT05623839

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-16

Study Completion Date

2023-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3305677

LY3305677 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3305677

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

ICON Early Phase Services

San Antonio, Texas, United States

Site Status

ICON Early Phase Services Lenexa Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Bhattachar SN, Tham LS, Li Y, Chua L, Ng SX, Tang Y, Ibriga H, Ni W, Gurbuz S, Mather KJ, Thomas MK. Mazdutide reduces body weight in adults with overweight or obesity: A high-dose Phase 1 trial. Diabetes Obes Metab. 2025 Aug 20. doi: 10.1111/dom.70040. Online ahead of print.

Reference Type DERIVED
PMID: 40832785 (View on PubMed)

Other Identifiers

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I8P-MC-OXAG

Identifier Type: OTHER

Identifier Source: secondary_id

18522

Identifier Type: -

Identifier Source: org_study_id

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