A Study of LY3305677 in Participants With Obesity Or Overweight

NCT05623839 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18522I8P-MC-OXAG
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (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

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

  Baseline through Week 20

Secondary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677

  Predose up to 72 hours postdose

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

  Predose up to 72 hours postdose

• Pharmacodynamics (PD): Percentage change in Body Weight

  Baseline through Week 20

Study Arms (2)

LY3305677

EXPERIMENTAL

LY3305677 administered subcutaneously (SC)

Drug: LY3305677

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3305677 DRUG

Administered SC

LY3305677

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

ICON Early Phase Services Lenexa Center

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• 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 Nov;27(11):6460-6469. doi: 10.1111/dom.70040. Epub 2025 Aug 20.

  PMID: 40832785 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 21, 2022
• Study Start: November 16, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)