Completed

Orforglipron on Body Composition in Obesity or Overweight

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What is being tested

Orforglipron

+ Placebo

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 17, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how a new medication called orforglipron affects body fat in adults who are overweight or have obesity but do not have diabetes. The goal is to compare the effects of this drug with a placebo, which is an inactive substance, to see if orforglipron can help reduce body fat. This research is important as it could lead to new treatment options for managing obesity, a condition that affects many people and can lead to other health issues. Participants in this study will be involved for about 8 months. During this time, they will receive either orforglipron or a placebo. The study is designed to carefully measure changes in body composition, specifically looking at the amount of body fat. The process is designed to ensure safety and collect accurate data on the drug's effects. By comparing results from the two groups, researchers aim to determine if orforglipron effectively reduces body fat.

Official TitleA Phase 1, Double-blind, Two-arm, Mechanism of Action Study to Investigate the Effect of Orforglipron on Body Composition in Adult Participants With Obesity or Overweight, Without Diabetes
NCT06824051
Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

1 inclusion criteria required to participate
Have a Body Mass Index (BMI) ≥30.0 kilograms per square meter (kg/m2), or ≥27.0 kg/m2 with comorbidities
4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive orforglipron orally

Group II

Placebo
Participants will receive placebo orally

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Clinical Pharmacology of Miami

Miami, United StatesOpen Clinical Pharmacology of Miami in Google Maps
Suspended

Axis

Dilworth, United States
Suspended

Ohio Clinical Trials

Columbus, United States
Suspended

Endeavor Clinical Trials

San Antonio, United States
Completed4 Study Centers