NCT06824051

Brief Summary

The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 27, 2025

Last Update Submit

February 24, 2026

Conditions

ObesityOverweight

Keywords

Visceral adipose tissueEnergy intake

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Visceral Adipose Tissue (VAT)

    Baseline, Week 36

Secondary Outcomes (6)

  • Percent Change from Baseline in Energy Intake

    Baseline, Week 36

  • Percent Change from Baseline in Appetite

    Baseline, Week 36

  • Percent Change from Baseline in Body Weight

    Baseline, Week 36

  • Percent Change from Baseline in Fasting Total Cholesterol

    Baseline, Week 36

  • Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

    Baseline, Week 36

  • +1 more secondary outcomes

Study Arms (2)

Orforglipron

EXPERIMENTAL

Participants will receive orforglipron orally

Drug: Orforglipron

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally

Drug: Placebo

Interventions

OrforglipronDRUG

Administered orally

Also known as: LY3502970
Orforglipron
PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a Body Mass Index (BMI)
  • ≥30.0 kilograms per square meter (kg/m2), or
  • ≥27.0 kg/m2 with comorbidities

You may not qualify if:

  • Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have an unstable body weight within 90 days prior to screening
  • Have acute or chronic hepatitis
  • Are taking other medications or alternative remedies to manage weight loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

Location

Axis

Dilworth, Minnesota, 56529, United States

Location

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

orforglipron

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 13, 2025

Study Start

February 17, 2025

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)