OverweightPhase 3NCT06047548
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
A Phase 3 study testing Tirzepatide in people with Overweight and Obesity, run by Eli Lilly and Company at 20 sites in United States.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 441 participants
- Where
- 20 sitesUnited States
- Study dates
- 20 Sep 2023to 20 Jan 2026
- 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 a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
- Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Who cannot join
- Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
- Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening.
- Have a history of chronic or acute pancreatitis
- Have any of the following cardiovascular conditions within 3 months prior to week 0.
- Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
Show all 9Show fewer
- family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Any lifetime history of a suicide attempt
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37397
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Prime Health and Wellness/SKYCRNG
Fayette, Mississippi, 39069
Asha Clinical Research - Munster
Hammond, Indiana, 46324
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Velocity Clinical Research, Westlake
Los Angeles, California, 90057
L-MARC Research Center
Louisville, Kentucky, 40213
Southern Endocrinology Associates
Mesquite, Texas, 75149
New Horizon Research Center
Miami, Florida, 33165
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Oviedo Medical Research
Oviedo, Florida, 32765
Cahaba Research - Pelham
Pelham, Alabama, 35124
Pinnacle Clinical Research
San Antonio, Texas, 78229
Southern California Dermatology, Inc.
Santa Ana, California, 92701
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Encompass Clinical Research
Spring Valley, California, 91978
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
About this study
Official title: A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Read the detailed description
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.
- Conditions
- Overweight, Obesity
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide 5 milligram (mg) | Experimental | Participants will receive tirzepatide subcutaneously (SC). Receives: Drug: Tirzepatide |
| Tirzepatide Maximum Tolerated Dose | Experimental | Participants will receive tirzepatide SC. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants will receive placebo. 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 (BW) Reduction Achieved during the 60-Week Weight Loss Period
Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau.
Measured: Week 112
Secondary outcomes (7)
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period
Assessment of (yes/no) of maintaining ≥80% of the BW reduction achieved during the 60-week weight loss period will be measured in participants who have reached a BW plateau.
Measured: Week 112
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
Assessment of (yes/no) of maintaining ≥15% BW reduction for participants who have already lost ≥15% BW at randomization will be measured in participants who have reached a BW plateau.
Measured: Week 112
Percent Change from Baseline in Body Weight
Measured: Baseline (Week 0), Week 112
Change from Randomization in Body Weight
Measured: Week 60, Week 112
Percent Change from Randomization in Body Weight
Measured: Week 60, Week 112
Change from Randomization in Waist Circumference
Measured: Week 60, Week 112
Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period
Measured: Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Sep 2023
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- 3b
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 441 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047548
- Sponsor's protocol ID
- 18720
- Other IDs
- I8F-MC-GPIQ
- Status last verified
- Mar 2026
- First submitted
- 14 Sep 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Horn DB, Aronne LJ, Wharton S, Bays HE, le Roux CW, Srinath R, Gomez-Valderas E, Arad AD, Das S, Dunn JP, Ribeiro A, Glass LC, Lee CJ. Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2026 Jun 6;407(10545):2305-2318. doi: 10.1016/S0140-6736(26)00656-2. Epub 2026 May 12.
PubMed 42119587Horn DB, Aronne LJ, Wharton S, Bays HE, Gomez-Valderas E, Arad AD, Sharma P, Dunn JP, Senyucel C, Lee CJ. Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN. Obesity (Silver Spring). 2025 Oct;33(10):1873-1885. doi: 10.1002/oby.70014. Epub 2025 Sep 7.
PubMed 40916045
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)
- ClinicalTrials.gov ID
- NCT06047548
- Acronym / sponsor ID
- 18720
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 21 Sep 2023 (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 tirzepatide for the maintenance of body weight reduction.
Detailed description
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 3b
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide 5 milligram (mg) | Experimental | Drug: TirzepatideParticipants will receive tirzepatide subcutaneously (SC). |
| Tirzepatide Maximum Tolerated Dose | Experimental | Drug: TirzepatideParticipants will receive tirzepatide SC. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Key exclusion criteria (9 listed)
- Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
- Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening
- Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening.
- Have a history of chronic or acute pancreatitis
- Have any of the following cardiovascular conditions within 3 months prior to week 0.
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 |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide 5 milligram (mg), Tirzepatide Maximum Tolerated Dose |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
Time frame: Week 112
Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau.
7 secondary outcomes
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period
Time frame: Week 112
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
Time frame: Week 112
Percent Change from Baseline in Body Weight
Time frame: Baseline (Week 0), Week 112
Change from Randomization in Body Weight
Time frame: Week 60, Week 112
Percent Change from Randomization in Body Weight
Time frame: Week 60, Week 112
Change from Randomization in Waist Circumference
Time frame: Week 60, Week 112
Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period
Time frame: Week 84
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 25 Mar 2026.
- Derived from this study: PubMed 42119587Horn DB, Aronne LJ, Wharton S, Bays HE, le Roux CW, Srinath R, Gomez-Valderas E, Arad AD, Das S, Dunn JP, Ribeiro A, Glass LC, Lee CJ. Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2026 Jun 6;407(10545):2305-2318. doi: 10.1016/S0140-6736(26)00656-2. Epub 2026 May 12.
- Derived from this study: PubMed 40916045Horn DB, Aronne LJ, Wharton S, Bays HE, Gomez-Valderas E, Arad AD, Sharma P, Dunn JP, Senyucel C, Lee CJ. Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN. Obesity (Silver Spring). 2025 Oct;33(10):1873-1885. doi: 10.1002/oby.70014. Epub 2025 Sep 7.
- A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related ComorbiditiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Overweight and Obesity, run by Eli Lilly and Company at 20 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 9 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 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 (BW) Reduction Achieved during the 60-Week Weight Loss Period (time frame: Week 112). 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 NCT06047548, which also lists 2 linked publications.
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 Mar 2026.