ObesityPhase 3ENLIGHTEN-1NCT07321886
A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes
A Phase 3 study testing Eloralintide in people with Obesity and Overweight, run by Eli Lilly and Company at 158 sites in 15 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of 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
- Obesity, Overweight
- 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
- 1,980 participants
- Where
- 158 sitesin 15 countries
- Study dates
- 6 Feb 2026to Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Body Mass Index (BMI) at screening of the following:
- 30 kilogram per square meter (kg/m2) OR
- 27 kg/m2 with at least one of the following weight-related health conditions at screening:
- high blood pressure
- dyslipidemia
- obstructive sleep apnea, or
Show all 9Show fewer
- heart disease
- Have a stable body weight (<5% body weight change) for 90 days prior to screening.
- Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
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 or type 2 diabetes
- Have had within 90 days prior to screening:
- heart attack
- stroke
Show all 11Show fewer
- 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
158 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
158 sites in 15 countries
United States41 sites, 41 recruiting
- Recruiting
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
505-224-7407
Satkirin Khalsa
- Recruiting
JEM Research Institute
Atlantis, Florida, 33462
561-968-2933
David Halpert
- Recruiting
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
443-444-6275
Adline Ghazi
- Recruiting
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
713-486-1350
Deborah Horn
- Recruiting
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Dan Lender
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390-9302
Amy Shah
- Recruiting
Teak Research Consults - Dunwoody
Dunwoody, Georgia, 30338
470-403-4755
Aakar Thaker
- Recruiting
Neighborhood Healthcare Institute of Health
Escondido, California, 92025
760-737-6984
James Schultz
- Recruiting
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
714-988-2021
Mark Leibowitz
- Recruiting
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
864-334-0141
Ronald Mayfield
- Recruiting
East-West Medical Research Institute
Honolulu, Hawaii, 96814
808-531-6886
Cindy Pau
- Recruiting
MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland, 20782
443-444-5663
Jean Park
- Recruiting
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601
337-602-6642
William Nabours
- Recruiting
AMR Clinical
Las Vegas, Nevada, 89119
702-597-9825
Michael Jacobs
- Recruiting
Teak Research Consults
Lawrenceville, Georgia, 30043
Kamar Alabi
- Recruiting
BioMed Research & Medical Center
Miami, Florida, 33156
786-238-7110
Liliam Hernandez
- Recruiting
Monroe Biomedical Research
Monroe, North Carolina, 28112
704-283-7359
Awawu Igbinadolor
- 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
AMR Clinical
Nashville, Tennessee, 37203
630-491-1900
Harvey Bowles
- Recruiting
AMR Clinical
Norfolk, Virginia, 23502
757-627-7446
Mary Bailey
- Recruiting
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
760-320-9505
Michael Jardula
- Recruiting
American Research Centers of Florida
Pembroke Pines, Florida, 33027
954-237-3799
Luis del Prado Rodriguez
- Recruiting
AHF Pensacola
Pensacola, Florida, 32503
850-476-3131 x53026
Mitchell Whitehead
- Recruiting
Care Access - Quincy
Quincy, Massachusetts, 02169
877-791-0656
Chih Chao Yang
- Recruiting
Rochester Clinical Research, LLC
Rochester, New York, 14609
585-288-0890
Leigh Schirmer
- Recruiting
Peninsula Research Associates
Rolling Hills Estates, California, 90274
310-265-1623
David Guzman
- Recruiting
Care Access - Sacramento
Sacramento, California, 95831
925-734-2331
Francisco Garcia
- Recruiting
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
210-692-7157
Priscilla Thomas
- Recruiting
Southern California Clinical Research
Santa Ana, California, 92701
714-474-2173
Wayne Ho
- Recruiting
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
480-725-8708
Benjamin Clark
- Recruiting
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, 33704
727-521-9137
Howard Chipman
- Recruiting
Clinical Research Atlanta
Stockbridge, Georgia, 30281
770-507-6867
Jason Agran
- Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
785-354-9591
Katherine Willingham
- Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
248-312-0025
Neil Fraser
- Recruiting
MFA Clinical Research
Tuscaloosa, Alabama, 35405
205-331-4963
Mohammad Aryanpure
- Recruiting
University Clinical Investigators, Inc.
Tustin, California, 92780
714-734-7944
John Kim
- Recruiting
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
724-912-0033
Paul Hartley
- Recruiting
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
Nancy Phillips
- Recruiting
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
203-437-6856
Jenna Langello
- Recruiting
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
Amy Keller
China14 sites, 14 recruiting
- Recruiting
Luhe Hospital
Beijing, 1001199
Dong Zhao
- Recruiting
Beijing Pinggu District Hospital
Beijing, 101200
13911080328
yufeng li
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Limin Tian
- Recruiting
West China Hospital Sichuan University
Chengdu, 610041
18980601658
zhenmei an
- 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
15318816218
Xiaolin Dong
- Recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471003
13653880139
Hongwei Jiang
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, 330038
13767035719
Zongyou Cheng
- Recruiting
Nanjing First Hospital
Nanjing, 210000
Qian Li
- Recruiting
Jiangsu Province Official Hospital
Nanjing, 210008
Wei Tang
- Recruiting
Zhongda Hospital Southeast University
Nanjing, 210009
Ling Li
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
18951762960
Yibing Lu
- Recruiting
Shanghai Sixth People's Hospital
Shanghai
Jian Zhou
Germany12 sites
- Active, not recruiting
Zentrum fur klinische Forschung - Köln
Cologne, 51069
- Active, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
- Active, not recruiting
StudyPoint Duisburg
Duisburg, 47269
- Active, not recruiting
InnoDiab Forschung Gmbh
Essen, 45136
- Active, not recruiting
Medizentrum Essen Borbeck
Essen, 45355
- Active, not recruiting
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109
- Active, not recruiting
AmBeNet GmbH
Leipzig, 04107
- Active, not recruiting
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
Lingen, 49808
- Active, not recruiting
BAG Drs. Med. Quist PartG
Mainz, 55128
- Active, not recruiting
CRS Clinical Research Services Mannheim
Mannheim, 68167
- Active, not recruiting
RED-Institut GmbH
Oldenburg, 23758
- Active, not recruiting
Praxis Sauter & Sauter & Vorbach
Wangen, 88239
Australia11 sites, 11 recruiting
- Recruiting
Emeritus Research
Botany, 2019
Paul Bird
- Recruiting
Core Research Group
Brisbane, 4064
61738765688
David Colquhoun
- Recruiting
Emeritus Research
Camberwell, 3124
Sam Francis
- Recruiting
Life Clinical Research
Ipswich, 4305
0734490036
Cameron Booth
- Recruiting
Paratus Clinical Research Central Coast
Kanwal, 2259
Ian Forsyth
- Recruiting
University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook
Meadowbrook, 4131
Ivan Lim
- Recruiting
Momentum Sunshine
Melbourne, 3021
0395096166
King Cheung
- Recruiting
Paratus Clinical Research - Melbourne
Melbourne, 3070
Kianoosh Noori Samie
- Recruiting
AIM Research
Merewether, 2291
+61 2 4963 2323
Claire Morbey
- Recruiting
Fusion Clinical Research
Norwood, 5067
Thomas Polasek
- Recruiting
USC Clinical Trials Sunshine Coast
Sippy Downs, 4556
Robert Scott
Argentina10 sites, 10 recruiting
- Not yet recruiting
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012
5491169680411
María Scioscia
- Not yet recruiting
Cicemo Srl
Buenos Aires, 1424
5491157417654
Pablo Costanzo
- Not yet recruiting
Cardiología Palermo
Buenos Aires, 1425
5491140306347
Paula Perez Terns
- Not yet recruiting
Glenny Corp. S.A.
Buenos Aires, 1430
01145445522
Martin Koretzky
- Not yet recruiting
CARDIAMET Investigaciones Médicas
Buenos Aires, C1014ACP
5491165496764
Angela Romero Zarante
- Not yet recruiting
Centro Médico Viamonte
Buenos Aires, C1120AAC
54 1149635650
Diego Aizenberg
- Not yet recruiting
Fundación Respirar
Buenos Aires, C1426ABP
5411 7078 1548
Marina Uhrig
- Not yet recruiting
Instituto de Investigaciones Clínicas Córdoba
Córdoba, 5000
03515102154
Mauro Pautasso
- Not yet recruiting
INECO Neurociencias Oroño
Rosario, 2000
(0341) 425 8695
María Cappiello
- Not yet recruiting
Centro Modelo de Cardiología
San Miguel de Tucumán, 4000
3814444500
GUILLERMO MERCAU
India10 sites, 10 recruiting
- Recruiting
Endolife Speciality Hospitals
Guntur, 522001
9849945577
Kongara Srikanth
- Recruiting
Gauhati Medical College and Hospital
Guwahati, 781032
9954658926
Anjan Talukdar
- Recruiting
Care Hospitals Hyderabad- Banjara Hills
Hyderabad, 500034
91 8008646165
Bipin Sethi
- Recruiting
Mandya Institute Of Medical Sciences
Mandya, 571401
GV Anikethana
- Recruiting
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, 400008
9819893087
Jugal Gada
- Recruiting
Mysore Medical College
Mysore, 570001
7760218464
Sumaiya Anjum
- Recruiting
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, 441108
9930805548
Udit Narang
- Recruiting
Supe Heart & Diabetes Hospital and Research Centre
Nashik, 422002
Pravin Supe
- Recruiting
Lifepoint Multispeciality Hospital
Pune, 411057
09730475068
Amol Dange
- Recruiting
Prabhu Diabetes Multi-Speciality Centre
Trichy, 620001
Venkatesan Ravindranath
Canada9 sites, 9 recruiting
- Recruiting
Aggarwal and Associates Limited
Brampton, L6T 0G1
9054589033
Naresh Aggarwal
- Recruiting
Med Trust Research
Courtice, L1E 2J5
905-728-7915 ext. 5
Anojan Kathirkamanayagan
- Recruiting
Dawson Clinical Research Inc.
Guelph, N1H 1B1
519-222-8251
Garry Wallace
- Recruiting
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, L8L 5G8
9055238134 x 274
Mateen Akhtar
- Recruiting
Alpha Recherche Clinique
Québec, G2J 0C4
418-704-1112
Anne-Marie Beaulieu
- Recruiting
ALPHA Recherche Clinique
Québec, G3K 2P8
418-847-1112
Maggie Lévesque
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
1 (519) 344-6612
John O'Mahony
- Recruiting
Winterberry Research Inc.
Stoney Creek, L8J 0B6
365-366-6267
Steven Zizzo
- Recruiting
Diex Recherche Inc. Division Trois-Rivieres
Trois-Rivières, G9A 4P3
Jean-francois Naud
Japan9 sites, 9 recruiting
- Recruiting
Adachi Kyosai Hospital
Adachi-ku, 120-0022
81120023812
Manabu Yamamoto
- Recruiting
Nihonbashi Sakura Clinic
Chūōku, 103-0025
81120023812
Kumie Ito
- Recruiting
Medical Corporation Chiseikai Tokyo Center Clinic
Chūōku, 103-0027
81120023812
Aki Tsuji
- Recruiting
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027
81120023812
Arihiro Kiyosue
- Recruiting
Boocs Clinic Fukuoka
Fukuoka, 812-0025
81120023812
Minoru Fujino
- Recruiting
Patient First Clinic Ginza-Shimbashi
Minato, 105-0004
81120023812
Kimihiro Hayashi
- Recruiting
Kanno Naika
Mitaka, 181-0013
81120023812
Kazuo Kanno
- Recruiting
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, 565-0853
81120023812
Yuko Soma
- Recruiting
Higashi Shinjuku Clinic
Tokyo, 169-0072
81120023812
Hiroaki Kondo
Poland9 sites, 9 recruiting
- Recruiting
Zdrowie Osteo-Medic
Bialystok, 15-351
48504055959
Katarzyna Wasilewska
- Recruiting
Legeartis - Poradnie Specjalistyczne
Bialystok, 15-404
48 507 18 11 18
Anna Modzelewska
- 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
Gabinety TERPA
Lublin, 20-333
48814427272
Beata Matyjaszek-Matuszek
- Recruiting
Ekamed
Lublin, 20-718
48603787884
Ewa Skokowska
- Recruiting
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, 60-589
48662023004
Pawel Bogdanski
- Recruiting
Pracownia Badań Klinicznych Salus
Wroclaw, 53-034
607424301
Katarzyna Madziarska
- Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, 41-800
48 32 271 25 11
Janusz Gumprecht
United Kingdom9 sites, 9 recruiting
- Recruiting
Layton Medical Centre
Blackpool, FY3 7EN
441253951943
Rebecca Clark
- Recruiting
Bradford on Avon Health Centre
Bradford on Avon, BA15 1DQ
01225866611
Nell Wyatt
- Recruiting
Ashton Medical Group - Chapel House
Lancashire, OL6 6EW
Omair Razzaq
- Recruiting
Royal Lancaster Infirmary
Lancaster, LA1 4RP
Mohamed Elnaggar
- Recruiting
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Alex Miras
- Recruiting
Bodyline Clinic - Openshaw
Manchester, M11 1AA
Sandra Connell
- Recruiting
Wansford Research Limited
Peterborough, PE8 6PL
Matthew Davies
- Recruiting
Abbeywell Surgery
Romsey, SO51 7QN
01794 512218
Nicola Lester
- Recruiting
Rame Group Practice
Torpoint, PL11 2TB
01752 817900
Georgina Hatton
Brazil8 sites, 7 recruiting
- Not yet recruiting
Chronos Pesquisa Clínica
Brasília, 72145-450
Maira Polcheira
- Not yet recruiting
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080
55 19 3267 0023
Sylka Rodovalho
- Suspended
Private Practice - Dr.Miguel N. Hissa
Fortaleza, 60430-350
- Not yet recruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília, 17504-072
55 14 21051477
José Sgarbi
- Not yet recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, 90430-001
555137796400
Luis Henrique Canani
- Not yet recruiting
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180
552125277979
Renata Alexandra Pinheiro
- Not yet recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
552135979708
Luiza Siffert
- Not yet recruiting
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
551122713450
Breno Balabem Alves
South Korea5 sites, 5 recruiting
- Recruiting
Gachon University Gil Medical Center
Namdong-gu, 21565
+82-32-458-2778
Kyoung-Kon Kim
- Recruiting
Konyang University Hospital
Seogu, 35365
Jee Hyun Kang
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Kiheon Lee
- Recruiting
Seoul National University Hospital
Seoul, 03080
82220723497
Minseon Park
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
82-55-360-2860
Sang Yeoup Lee
Taiwan5 sites, 5 recruiting
- Recruiting
Chiayi Christian Hospital
Chiayi City, 600
886-5-2765041
Chu-Kuang Chou
- 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
886 975056106
Chih-Yuan Fang
- Recruiting
National Taiwan University Hospital
Taipei, 10002
0223123456
Chih-Yuan Wang
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Kang-Ling Wang
Belgium4 sites, 4 recruiting
- Recruiting
ANIMA Research
Diepenbeek, 3590
+32 11 94 91 15
Hilde Bollen
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
011337030
Guido Claessen
- Recruiting
Kormont
Kluisbergen, 9690
32 496 376259
Klaas Vercruysse
- Recruiting
Gezondheidshuis De Gloed
Machelen, 9870
32 496 376259
Klaas Vercruysse
Puerto Rico2 sites, 2 recruiting
- Recruiting
Puerto Rico Health and Wellness Institute
Dorado, 00646
7877961049
Elham Ghorbani
- Recruiting
Wellness clinical Research Vega Baja
Vega Baja, 00693
787-654-9444
Gustavo Albizu Angulo
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, Without Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.
Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
- Conditions
- Obesity, Overweight
- Being tested
- Eloralintide, Placebo
- Medical subject headings
- Obesity, Overweight
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 (18)
Percent Change from Baseline in Total Body Fat Mass
Measured: Baseline, Week 64
Change from Baseline in Waist Circumference
Measured: Baseline, Week 64
Percent Change from Baseline in Triglycerides
Measured: Baseline, Week 64
Change from Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 64
Time to Onset of Type 2 Diabetes (T2D)
Time to Onset of Type 2 Diabetes (T2D) in Participants with Prediabetes at Randomization
Measured: Baseline to Week 168 and Week 191
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Measured: Baseline, Week 64
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Measured: Baseline, Week 64
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, Week 64
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score
Measured: Baseline, Week 64
Change from Baseline in EQ-5D-5L
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 Improvement of Status (PGIS) Physical Function Weight
Measured: Baseline, Week 64
Change in Medication Use
Measured: Baseline through Week 64
Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization
Measured: Baseline, Week 168
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 posted7 Jan 2026
- Study start6 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,980 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
- NCT07321886
- Sponsor's protocol ID
- 27742
- Other IDs
- J3R-MC-YDAG, 2025-523657-34-00, 2025
- Acronym
- ENLIGHTEN-1
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07321886
- Acronym / sponsor ID
- ENLIGHTEN-1 / 27742
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,980 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 7 Jan 2026 (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 purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.
Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eloralintide Dose 1 | Experimental | Drug: EloralintideParticipants will receive eloralintide subcutaneously (SC) |
| Eloralintide Dose 2 | Experimental | Drug: EloralintideParticipants will receive eloralintide SC |
| Eloralintide Dose 3 | Experimental | Drug: EloralintideParticipants will receive eloralintide SC |
| Eloralintide Dose 4 | Experimental | Drug: EloralintideParticipants will receive eloralintide SC |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have Body Mass Index (BMI) at screening of the following:
- Have a stable body weight (<5% body weight change) for 90 days prior to screening.
- Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
Key exclusion criteria (11 listed)
- 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 or type 2 diabetes
- Have had within 90 days prior to screening:
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
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 |
|---|---|---|
| EloralintideAlso: LY3841136Administered SC | Drug | Eloralintide Dose 1, Eloralintide Dose 2, Eloralintide Dose 3, Eloralintide Dose 4 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 64
18 secondary outcomes
Percent Change from Baseline in Total Body Fat Mass
Time frame: Baseline, Week 64
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 64
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 64
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 64
Time to Onset of Type 2 Diabetes (T2D)
Time frame: Baseline to Week 168 and Week 191
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 64
Percent Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 64
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 64
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 64
Change from Baseline in Short Form-36 Version 2 (SF-36 v2) Score
Time frame: Baseline, Week 64
Change from Baseline in EQ-5D-5L
Time frame: Baseline, Week 64
Change from Baseline in Control of Eating Questionnaire (CoEQ) Score
Time frame: Baseline, Week 64
Achievement of Improved Categorical Shift in Patient Global Improvement of Status (PGIS) Physical Function Weight
Time frame: Baseline, Week 64
Change in Medication Use
Time frame: Baseline through Week 64
Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization
Time frame: Baseline, Week 168
Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)
Time frame: Baseline through Week 64
PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Time frame: Baseline through Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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.
Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
158 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eloralintide in people with Obesity and Overweight, run by Eli Lilly and Company at 158 sites in 15 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 158 sites in United States, China, Germany, Australia, Argentina and 10 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Body Weight (time frame: Baseline, Week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.