Placebo to match LY
Sponsors
Eli Lilly & Co.
Conditions
Alcohol Use DisorderAlzheimer DiseaseAlzheimer’s DiseaseAsthmaChronic Low Back Pain (CLBP)Diabetes MellitusGZP1GZP2: Obesity
Phase 2
I5T-MC-AACI: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
CompletedCTIS2023-507303-55-00
Start: 2020-09-30End: 2025-09-17Target: 224Updated: 2025-01-23
J1R-MC-GZFD: A Parallel-Group Treatment, Phase 2, Double-Blind study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants with Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide who Failed to Achieve HbA1c Goal
RecruitingCTIS2024-520328-27-00
Start: 2025-08-07Target: 59Updated: 2025-11-25
J2S-MC-GZMR: A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Uncontrolled Moderate to Severe Asthma
Not yet recruitingCTIS2025-522640-41-00
Target: 73Updated: 2026-01-21
J6E-MC-KWAN: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis
Not yet recruitingCTIS2025-522338-30-00
Target: 9Updated: 2026-03-20
Phase 3
J5P-MC-GZRA: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (ATTAIN-OSA); J5P-MC-GZ01: Participants with OSA unable or unwilling to use PAP therapy; J5P-MC-GZ02: Participants with OSA on PAP therapy
Active, not recruitingCTIS2024-515905-25-00
Start: 2025-01-29Target: 118Updated: 2025-06-26
J1G-MC-LAKI: A Study of Remternetug Versus Placebo in Early Alzheimer’s Disease Participants at Risk for Cognitive and Functional Decline
Active, not recruitingCTIS2024-515656-20-00
Start: 2025-04-15Target: 43Updated: 2025-11-24
J1I-MC-GZQD: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7)
CompletedCTIS2024-517431-43-00
End: 2025-10-06Target: 85Updated: 2025-09-12
J2A-MC-GZPL: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION);
J2A-MC-GZL1: Participants with Hypertension and Obesity or Overweight;
J2A-MC-GZL2: Participants with Hypertension and Obesity or Overweight
Active, not recruitingCTIS2024-519000-27-00
Start: 2025-07-17Target: 422Updated: 2025-12-01
J2A-MC-GZPO: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared with Placebo in Participants with Obesity or Overweight with and without Type 2 Diabetes. J2A-MC-GZP1: Participants with obesity or overweight with at least 1 weight-related comorbidity, without type 2 diabetes.
J2A-MC-GZP2: Participants with obesity or overweight with type 2 diabetes
Active, not recruitingCTIS2025-521098-14-00
Start: 2025-08-15Target: 198Updated: 2026-01-23
I4V-MC-JAJJ: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years
RecruitingCTIS2025-521797-34-00
Start: 2026-01-20Target: 97Updated: 2026-01-12
J2A-MC-GZPT A Phase 3 Study to Investigate the Efficacy and Safety of Orfor-glipron Once Daily in Participants Who Have Obesity or Overweight and Osteoar-thritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Pla-cebo-Controlled Trial
List of Intervention-Specific Appendices (ISAs):
ISA1 (GZT1): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
ISA2 (GZT2): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
RecruitingCTIS2025-522631-34-00
Start: 2026-01-14Target: 180Updated: 2026-01-11
J2A-MC-GZPS: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared with Placebo in Female Participants with Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI) ;
J2A-MC-GZS1: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight ;
J2A-MC-GZS2: A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants with Stress Urinary Incontinence Who Have Obesity or Overweight
Not yet recruitingCTIS2025-522514-23-00
Target: 160Updated: 2026-01-26
N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD
Not yet recruitingCTIS2025-522674-36-00
Target: 170Updated: 2026-01-29
J2S-MC-GZMP: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Alcohol Use Disorder (RENEW-ALC-2)
Not yet recruitingCTIS2025-522312-16-00
Target: 67Updated: 2026-01-29
I4V-MC-JAJK: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years
Not yet recruitingCTIS2025-522170-36-00
Target: 60Updated: 2026-02-03
J2S-MC-GZME: A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared with Placebo for the Treatment of Adult Participants with Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)
Not yet recruitingCTIS2025-522313-38-00
Target: 47Updated: 2026-02-05
J2A-MC-GZPR: A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants with Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial
Not yet recruitingCTIS2025-523283-21-00
Target: 85Updated: 2026-02-17
J3R-MC-YDAO - A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight (ENLIGHTEN-3)
Intervention-Specific Appendices (ISAs):
J3R-MC-YSA1: Participants unable or unwilling to use positive airway pressure therapy
J3R-MC-YSA2: Participants treated with positive airway pressure therapy
Not yet recruitingCTIS2025-523769-11-00
Target: 85Updated: 2026-03-20
J3R-MC-YDAG - 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
Not yet recruitingCTIS2025-523657-34-00
Target: 62Updated: 2026-03-27
J3R-MC-YDAN - A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)
J3R-MC-YOA1: Intervention-Specific Appendix 1 (ISA1) for Eloralintide in Participants with Osteoarthritis Knee Pain
J3R-MC-YOA2: Intervention-Specific Appendix 2 (ISA2) for Eloralintide in Participants with Osteoarthritis Knee Pain
Not yet recruitingCTIS2025-523768-19-00
Target: 20Updated: 2026-04-02