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ObesityPhase 1NCT06824051

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight

A Phase 1 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
4 sitesUnited States
Study dates
17 Feb 2025to 26 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Ohio Clinical Trials

    Columbus, Ohio, 43212

  • Axis

    Dilworth, Minnesota, 56529

  • Clinical Pharmacology of Miami

    Miami, Florida, 33172

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: A 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

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.

Conditions
Obesity, Overweight
Being tested
Orforglipron, Placebo
Keywords
Visceral adipose tissue, Energy intake
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06824051
Study groupRoleWhat they receive
OrforglipronExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
PlaceboPlacebo comparatorParticipants will receive placebo orally
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Visceral Adipose Tissue (VAT)

    Measured: Baseline, Week 36

Secondary outcomes (6)

  1. Percent Change from Baseline in Energy Intake

    Measured: Baseline, Week 36

  2. Percent Change from Baseline in Appetite

    Measured: Baseline, Week 36

  3. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 36

  4. Percent Change from Baseline in Fasting Total Cholesterol

    Measured: Baseline, Week 36

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

    Measured: Baseline, Week 36

  6. Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores

    Measured: Baseline, Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start17 Feb 2025
  3. Primary completion26 Jan 2026
  4. Study completion26 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824051
Sponsor's protocol ID
27352
Other IDs
J2A-MC-GZPQ
Status last verified
Feb 2026
First submitted
27 Jan 2025
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Visceral Adipose Tissue (VAT) (time frame: Baseline, Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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