ObesityPhase 3NCT06584916
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)
A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 29 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830). 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
- 376 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 13 Sep 2024to 21 Nov 2025
- Phase
- Phase 3
- 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 completed the SURMOUNT-5 study (NCT05822830; a trial of injectable tirzepatide [Zepbound] versus injectable semaglutide [Wegovy]) on study treatment
Who cannot join
- Have Type 1 Diabetes, Type 2 Diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- Have a prior or planned surgical treatment for obesity
- Have acute or chronic hepatitis
- Have a history of acute or chronic pancreatitis
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
Cahaba Research
Birmingham, Alabama, 35242
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37421
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
North Texas Endocrine Center
Dallas, Texas, 75231
Lillestol Research
Fargo, North Dakota, 58104
Prime Health and Wellness/SKYCRNG
Fayette, Mississippi, 39069
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Biopharma Informatic, LLC
Houston, Texas, 77043
PlanIt Research, PLLC
Houston, Texas, 77079
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
Palm Research Center Sunset
Las Vegas, Nevada, 89148
L-MARC Research Center
Louisville, Kentucky, 40213
Southern Endocrinology Associates
Mesquite, Texas, 75149
New Horizon Research Center
Miami, Florida, 33165
Weill Cornell Medical College
New York, New York, 10021
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Cahaba Research - Pelham
Pelham, Alabama, 35124
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Encompass Clinical Research
Spring Valley, California, 91978
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
University Clinical Investigators, Inc.
Tustin, California, 92780
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Puerto Rico2 sites
Puerto Rico Medical Research
Ponce, 00717
Wellness clinical Research Vega Baja
Vega Baja, 00694
About this study
Official title: A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).
Read the detailed description
All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.
- Conditions
- Obesity, Overweight
- Being tested
- Orforglipron, Placebo
- Keywords
- Maintenance, Weight maintenance, Body weight changes, Weight loss, Incretins, Hormones, Hormone substitutes, Hormone antagonists, Physiological effects of drugs, tirzepatide, semaglutide, Zepbound, Wegovy, injectable GLP-1, oral GLP-1, incretin therapy, GLP-1 receptor agonist, crossover from injectable
- Medical subject headings
- Obesity, Overweight, Body Weight Changes, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Orforglipron | Experimental | Participants will receive orforglipron orally Receives: Drug: Orforglipron |
| Placebo | Placebo comparator | Participants will receive placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Measured: Week 52
Secondary outcomes (5)
Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment
Measured: Week 52
Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5
Measured: Week 52
Change from Baseline in Body Weight
Measured: Baseline, Week 52
Change from Baseline in Waist Circumference
Measured: Baseline, Week 52
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start13 Sep 2024
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3b
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584916
- Sponsor's protocol ID
- 27239
- Other IDs
- J2A-MC-GZPN
- Status last verified
- Jun 2026
- First submitted
- 3 Sep 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Aronne LJ, Horn DB, le Roux CW, Chao AM, Ho W, Halpern B, Griffin R, Xie C, Valderas EG, Lee CJ, Ribeiro A, Hyman DM, Glass L, Xavier N. Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial. Nat Med. 2026 Jul;32(7):2679-2687. doi: 10.1038/s41591-026-04386-7. Epub 2026 May 13.
PubMed 42120723
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
- ClinicalTrials.gov ID
- NCT06584916
- Acronym / sponsor ID
- 27239
- Conditions
- Obesity, Overweight
- Keywords
- Maintenance, Weight maintenance, Body weight changes, Weight loss, Incretins, Hormones, Hormone substitutes, Hormone antagonists
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).
Detailed description
All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase 3b
| Arm | Type | Receives |
|---|---|---|
| Orforglipron | Experimental | Drug: OrforglipronParticipants will receive orforglipron orally |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have completed the SURMOUNT-5 study (NCT05822830; a trial of injectable tirzepatide [Zepbound] versus injectable semaglutide [Wegovy]) on study treatment
Key exclusion criteria (4 listed)
- Have Type 1 Diabetes, Type 2 Diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- Have a prior or planned surgical treatment for obesity
- Have acute or chronic hepatitis
- Have a history of acute or chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrforglipronAdministered orally | Drug | Orforglipron |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Time frame: Week 52
5 secondary outcomes
Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment
Time frame: Week 52
Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5
Time frame: Week 52
Change from Baseline in Body Weight
Time frame: Baseline, Week 52
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 52
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 42120723Aronne LJ, Horn DB, le Roux CW, Chao AM, Ho W, Halpern B, Griffin R, Xie C, Valderas EG, Lee CJ, Ribeiro A, Hyman DM, Glass L, Xavier N. Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial. Nat Med. 2026 Jul;32(7):2679-2687. doi: 10.1038/s41591-026-04386-7. Epub 2026 May 13.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 29 sites in 2 countries.
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 1 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Maintenance of Body Weight Reduction Achieved in SURMOUNT-5 (time frame: Week 52). 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 NCT06584916, which also lists 1 linked publication.
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 4 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.