OverweightPhase 3ENLIGHTEN-2NCT07282600
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
A Phase 3 study testing Eloralintide in people with Overweight and Obesity, run by Eli Lilly and Company at 143 sites in 13 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks. 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?
- Eloralintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,035 participants
- Where
- 143 sitesin 13 countries
- Study dates
- 15 Dec 2025to Feb 2028
- Phase
- Phase 3
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 type 2 diabetes
- Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
- Have a BMI ≥ 27 kg/m2
- Have a stable body weight (<5% body weight change) for 90 days prior to screening
Who cannot join
- Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- Have type 1 diabetes
- Have taken any of the following antihyperglycemic medications within 90 days before screening:
- amylin analogs
- glucagon-like peptide-1 (GLP-1) receptor agonists
Show all 16Show fewer
- glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
- insulin
- Have had within 90 days prior to screening:
- heart attack
- stroke
- coronary artery revascularization
- unstable angina, or
- hospitalization due to congestive heart failure
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
- Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Trial locations and contacts
143 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
143 sites in 13 countries
United States60 sites, 60 recruiting
- Recruiting
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
505-224-7407
Satkirin Khalsa
- Recruiting
Care Access - Aurora
Aurora, Colorado, 80012
720-368-4865
Mauricio Waintrub
- Recruiting
IMA Clinical Research Austin
Austin, Texas, 78745
Yu-Mei Liu
- Recruiting
Birmingham Clinical Research
Birmingham, Alabama, 35209
205-870-4343
Nova Law
- Recruiting
New England Research Associates, LLC
Bridgeport, Connecticut, 06606
203-374-9816
Ilja Hulinsky
- Recruiting
San Fernando Valley Health Institute
Canoga Park, California, 91304
818-222-6868
Jeffrey London
- Recruiting
Clinical Research Professionals
Chesterfield, Missouri, 63005
636-220-1200
Timothy Jennings
- Recruiting
Centennial Medical Group
Columbia, Maryland, 21045
410-730-3399
Rajiv Dua
- Recruiting
Private Practice - Dr. Osvaldo A. Brusco
Corpus Christi, Texas, 78414
361-885-0448
Osvaldo Brusco
- Recruiting
Cullman Clinical Trials
Cullman, Alabama, 35055
256-708-2826
Randall Quinn
- Recruiting
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Dan Lender
- Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, 32117
386-278-8000
David Billmeier
- Recruiting
Care Access - Delray Beach
Delray Beach, Florida, 33484
401-773-7855
Sudhir Bansal
- Recruiting
Teak Research Consults - Dunwoody
Dunwoody, Georgia, 30338
470-403-4755
Aakar Thaker
- Recruiting
Hypertension & Nephrology Association
Eatontown, New Jersey, 07724
spiros Arbes
- Recruiting
AMCR Institute
Escondido, California, 92025
760-466-1520
Jenine Stone
- Recruiting
Lillestol Research
Fargo, North Dakota, 58104
701-232-7705
Michael Lillestol
- Recruiting
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
904-621-0390
Jennifer Sidey
- Recruiting
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132
817-263-0007
Anjanette Tan
- Recruiting
NorCal Medical Research, Inc
Greenbrae, California, 94904
415-461-1585
Linda Gaudiani
- Recruiting
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408
336-574-8020
Alexander Murray
- Recruiting
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
Jillian Reid
- Recruiting
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
808-526-0303
ALAN PARSA
- Recruiting
Juno Research
Houston, Texas, 77040
713-779-5494
Damaris Vega
- Recruiting
DM Clinical Research - Indianapolis
Indianapolis, Indiana, 46254
463-271-3050
Brandon Essink
- Recruiting
Nature Coast Clinical Research - Inverness
Inverness, Florida, 34452
352-341-2100
Paul Hellstern
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
904-730-0101
Jeffry Jacqmein
- Recruiting
Teak Research Consults
Lawrenceville, Georgia, 30043
Kamar Alabi
- Recruiting
Care Access - Lima
Lima, Ohio, 45805
Jimmy Alele
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
Martha Navarro
- Recruiting
NYC Research INC
Long Island City, New York, 11106
516-574-9232
Anastasios Manessis
- Recruiting
Pacific Clinical Studies
Los Alamitos, California, 90720
562-598-0600 ext 205
Etsegenet Ayele
- Recruiting
Inglewood Clinical
Los Angeles, California, 90056
310-693-5000
Maricor Grio
- Recruiting
The Jones Center Clinical Research
Macon, Georgia, 31210
Susan Garcia Castillo
- Recruiting
Southern Endocrinology Associates
Mesquite, Texas, 75149
214-693-0904
Sumana Gangi
- Recruiting
Clinical Trials Management, LLC d/b/a Flourish Research
Metairie, Louisiana, 70006
504-455-1310
David Dulitz
- Recruiting
Flourish Research Acquisition, LLC dba Flourish Research - North Miami
Miami, Florida, 33138
786-772-0411
Rimsky Denis
- Recruiting
New Horizon Research Center
Miami, Florida, 33165
305-226-3933
Lazaro Nunez
- Recruiting
IMA Clinical Research Monroe - Armand
Monroe, Louisiana, 71201
Clinton Guillory
- Recruiting
West Clinical Research
Morehead City, North Carolina, 28557
252-515-0050
Patrick Morgante
- Recruiting
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757
352-383-8222
Shirley Nagel
- Recruiting
Accellacare - Mt Pleasant
Mt. Pleasant, South Carolina, 29464
843-849-1880
Richard Mills
- Recruiting
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
508-720-2015
David Shih
- Recruiting
Ogden Clinic - Canyon View
Ogden, Utah, 84404
385-271-0684
Stephen Bruce
- Recruiting
American Research Centers of Florida
Pembroke Pines, Florida, 33027
954-237-3799
Luis del Prado Rodriguez
- Recruiting
Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
Pittsburgh, Pennsylvania, 15243
412-942-0023
Daniel Austin
- Recruiting
Research Your Health
Plano, Texas, 75093
9729991155 x103
Michele Reynolds
- Recruiting
Summit Headlands
Portland, Oregon, 97210
Andre Barkhuizen
- Recruiting
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
210-692-7157
Priscilla Thomas
- Recruiting
Diabetes & Endocrine Treatment Specialists
Sandy City, Utah, 84093
801-816-1010
Timothy Graham
- Recruiting
Care Access - Santa Clarita
Santa Clarita, California, 91321
661-371-7272
Sina Tebi
- Recruiting
NorthShore University Health System
Skokie, Illinois, 60077
847-663-8540
Liana Billings
- Recruiting
Encompass Clinical Research
Spring Valley, California, 91978
619-660-9068
Hanid Audish
- Recruiting
Clinvest Headlands Llc
Springfield, Missouri, 65807
417-883-7889
Cory Bethmann
- Recruiting
Tucson Clinical Research Institute
Tucson, Arizona, 85712
Girish Karamchandani
- Recruiting
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
724-438-1479
Richard Cook II
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
925-930-7267
Bonnie Kimmel
- Recruiting
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
Nancy Phillips
- Recruiting
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403
William Jones
- Recruiting
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
407-740-8078
Monica Aggarwal
China16 sites, 16 recruiting
- Recruiting
Luhe Hospital
Beijing, 100000
Dong Zhao
- Recruiting
Peking University People's Hospital
Beijing, 100034
13910978815
Linong Ji
- Recruiting
Beijing Pinggu District Hospital
Beijing, 101200
13911080328
yufeng li
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Limin Tian
- Recruiting
The Second Affiliated Hospital Chongqing Medical University
Chongqing, 400010
13594028475
Dongfang Liu
- Recruiting
Zhujiang Hospital
Guangzhou, 510280
Jia Sun
- Recruiting
The Second People's Hospital of Hefei
Hefei, 230011
86-13956099720
Jun Ye
- Recruiting
Jinan Central Hospital
Jinan, 250013
Nianrong Mi
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471023
13653880139
Hongwei Jiang
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, 330038
13767035719
Zongyou Cheng
- Recruiting
Nanjing First Hospital
Nanjing, 210006
Qian Li
- Recruiting
Jiangsu Province Official Hospital
Nanjing, 210008
Wei Tang
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
18951762960
Yibing Lu
- Recruiting
Jiading District Central Hospital
Shanghai, 201800
Lixia Suo
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, 300211
Yu Chen
- Recruiting
Zigong First People's Hospital
Zigong, 643000
Jian Li
Japan15 sites, 15 recruiting
- Recruiting
Hayashi Diabetes Internal Medicine Clinic
Chigasaki, 253-0044
81120023812
Tsutomu Hayashi
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Shonan Takai Clinic
Kamakura, 247-0055
81120023812
Kuninobu Takai
- Recruiting
Oishi Clinic
Kasuya-gun, 811-2310
81120023812
Yayoi Oishi
- Recruiting
OHAMA Diabetes Clinic
Kawaguchi, 332-0015
81120023812
Toshihiko Ohama
- Recruiting
Higashijujo Sakai Diabetes Internal Medicine Clinic
Kita-ku, 114-0001
81120023812
Koji Sakai
- Recruiting
Tokuyama Clinic
Mihama-ku,Chiba City, 261-0004
81120023812
Takahiko Tokuyama
- Recruiting
Shinkenko clinic
Naha, 900-0015
81120023812
Yoshiki Shiohira
- Recruiting
Oyama East Clinic
Oyama, 323-0022
81120023812
Kunihiro Suzuki
- Recruiting
Shimokitazawa Tomo Clinic
Setagaya-ku, 155-0031
81120023812
Tomofumi Murakami
- Recruiting
Soka Sugiura Internal Medicine Clinic
Sōka, 340-0015
81120023812
Tatsushi Sugiura
- Recruiting
Tsuchiura Medical & Health Care Center
Tsuchiura, 300-0012
81120023812
Natsuki Imoto
- Recruiting
Tsuchiura Beryl Clinic
Tsuchiura, 300-0062
81120023812
Kota Yamada
- Recruiting
Nagase Diabetes Clinic
Ushiku, 300-1207
81120023812
Terumasa Nagase
- Recruiting
Yokohama Minoru Clinic
Yokohama, 232-0064
81120023812
Chino Nakamura
Spain9 sites
- Active, not recruiting
Hospital Universitario de La Ribera
Alzira, 46600
- Active, not recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Active, not recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
- Active, not recruiting
Complejo Hospitalario Ruber Juan Bravo
Madrid, 28006
- Active, not recruiting
H.R.U Málaga - Hospital Civil
Málaga, 29009
- Active, not recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Active, not recruiting
Centro Médico Compostela
Santiago de Compostela, 15702
- Active, not recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
- Active, not recruiting
Vithas Hospital Sevilla
Seville, 41950
Poland8 sites, 8 recruiting
- Recruiting
Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna
Bialystok, 15445
48856520318
Grazyna Laszewska
- Recruiting
Centrum Medyczne NEUROMED
Bydgoszcz, 85-163
48696268565
Beata Lisewska
- Recruiting
Ambulatorium Sp. z o.o.
Elblag, 82-300
48608202021
Anna Bazela-Ostromecka
- Recruiting
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, 31-261
48126237122
Joanna Mirocka
- Recruiting
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-338
607536360
Malgorzata Jozefowska
- Recruiting
Ekamed
Lublin, 20-718
48603787884
Ewa Skokowska
- Recruiting
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Ruda Śląska, 41-709
48728814934
Henryk Rudzki
- Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, 41-800
48 32 271 25 11
Janusz Gumprecht
Germany7 sites
- Active, not recruiting
Diabetespraxis Dr. Braun
Berlin, 13187
- Active, not recruiting
Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann
Bünde, 32257
- Active, not recruiting
InnoDiab Forschung Gmbh
Essen, 45136
- Active, not recruiting
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109
- Active, not recruiting
Institut für Diabetesforschung GmbH Münster
Münster, 48145
- Active, not recruiting
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
Münster, 48153
- Active, not recruiting
RED-Institut GmbH
Oldenburg, 23758
Slovakia6 sites, 6 recruiting
- Recruiting
Diacrin s.r.o.
Bratislava, 83101
00421908956445
Eva Zakovicova
- Recruiting
MediVet s.r.o.
Malacky, 901 01
00421905565208
Eva Pavleova
- Recruiting
B-Medical, s.r.o.
Námestovo, 02901
421948014007
Maria Balekova
- Recruiting
FUNKYSTUFF s.r.o.
Nové Zámky, 940 02
421 35 6420 746
Miriam Teplanova
- Recruiting
DIA-MED CENTRUM s.r.o.
Púchov, 020 01
421423810145
Ludmila Kubincova
- Recruiting
MEDI-DIA s.r.o.
Sabinov, 083 01
421907230520
Martina Merciakova
Mexico5 sites, 5 recruiting
- Not yet recruiting
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, 44260
523312044280
Emilia Pelayo Orozco
- Not yet recruiting
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, 44600
+523336153477
Guillermo Gonzalez Galvez
- Not yet recruiting
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
Guadalajara, 44670
523336422886
Marisol Herrera Marmolejo
- Not yet recruiting
Medical Care and Research SA de CV
Mérida, 97070
9992211846
José Cetina Canto
- Not yet recruiting
Cardiolink Clin Trials
Monterrey, 64060
8140401554
Elias Alberto Garcia Cantu
South Korea5 sites, 5 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si, 15355
82314124274
NANHEE KIM
- Recruiting
Hanyang University Guri Hospital
Guri-si, 11923
Chang Beom Lee
- Recruiting
Chosun University Hospital
Gwangju, 61453
Sang Yong Kim
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Soo Lim
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Byung Wan Lee
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
886-7-3121101 ext 7741
Tsung-Hsien Lin
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301
+886912159389
Jung-Fu Chen
- Recruiting
National Taiwan University Hospital
Taipei, 10002
0223123456
Chih-Yuan Wang
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
886228757516
Chii-Min Hwu
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Chia-Hung Lin
Czechia4 sites
- Active, not recruiting
MUDr. Tomas Edelsberger
Krnov, 79401
- Active, not recruiting
MUDr. Miroslav Koliba s.r.o.
Ostrava, 702 00
- Active, not recruiting
MUDr. Jana Parkanyiova
Prague, 110 00
- Active, not recruiting
Diabet2 s.r.o., diabetologicka a interni ambulance
Prague, 11000
Puerto Rico2 sites, 2 recruiting
- Recruiting
Centro de Endocrinologia y Nutricion
Caguas, 00725
7877467057
Juan Otero-Martinez
- Recruiting
Dorado Medical Complex
Dorado, 00646
787-278-1576
Luis Pagan-Cardona
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, and Type 2 Diabetes
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.
- Conditions
- Overweight, Obesity
- Being tested
- Eloralintide, Placebo
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EloralintideDrug
Also called LY3841136
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide Dose 1 | Experimental | Participants will receive eloralintide subcutaneously (SC) Receives: Drug: Eloralintide |
| Eloralintide Dose 2 | Experimental | Participants will receive eloralintide SC Receives: Drug: Eloralintide |
| Eloralintide Dose 3 | Experimental | Participants will receive eloralintide SC Receives: Drug: Eloralintide |
| Eloralintide Dose 4 | Experimental | Participants will receive eloralintide SC Receives: Drug: Eloralintide |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 64
Secondary outcomes (16)
Percent Change from Baseline in Total Body Fat Mass
Measured: Baseline, Week 64
Change from Baseline in Waist Circumference
Measured: Baseline, Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 64
Percent Change in Baseline in Triglycerides
Measured: Baseline, Week 64
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, Week 64
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 64
Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Measured: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Measured: Baseline, Week 64
Change in Medication Use
Measured: Baseline through Week 64
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Score
Measured: Baseline, Week 64
Change from Baseline in EQ-5D-5L Score
Measured: Baseline, Week 64
Change from Baseline in Control of Eating Questionnaire (CoEQ) Score
Measured: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight
Measured: Baseline, Week 64
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
Measured: Baseline through Week 64
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Measured: Baseline through Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Dec 2025
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,035 participants (estimated)
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
- NCT07282600
- Sponsor's protocol ID
- 27741
- Other IDs
- J3R-MC-YDAF, 2025-523658-15-00, 2025
- Acronym
- ENLIGHTEN-2
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.