Retatrutide clinical trials

Status: Retatrutide is investigational and not approved by the FDA or any other regulator. Eli Lilly has said it plans to submit a Biologics License Application to the FDA in the first quarter of 2027; no submission, priority review or decision date has been announced.

Head-to-head evidence: One randomized comparison has reported: TRANSCEND-T2D-2, an open-label trial in type 2 diabetes against semaglutide 2 mg (Ozempic), so far only as a topline press release. The comparison with tirzepatide, TRIUMPH-5, is registered and has not reported.

20 trials tracked: 10 with reported results, 10 registered without results yet. Verified against each source on .

Retatrutide is a once-weekly injected agonist of three receptors: GIP, GLP-1 and glucagon. Semaglutide acts on GLP-1 alone and tirzepatide on GIP and GLP-1; the glucagon receptor is the addition, intended to raise energy expenditure. Its half-life is approximately 6 days (phase 1b).

Research and educational reference only. Trial arms are the regimens studied under medical supervision, not an amount for anyone to take. Nothing here is medical advice.

All trials at a glance

Retatrutide trials: phase, population, size, comparator, status and whether results are reported
TrialPhasePopulationSizeComparatorStatusResults
TRIUMPH-1NCT059290663Adults with obesity or overweight without type 2 diabetes (with knee osteoarthritis and sleep apnea substudies)2,339PlaceboCompletedPublished, Topline (press release)
TRIUMPH-2NCT059290793Adults with type 2 diabetes and obesity or overweight1,152PlaceboCompletedPublished
TRIUMPH-3NCT058820453Adults with severe obesity and established cardiovascular disease1,949PlaceboCompletedTopline (press release)
TRIUMPH-4NCT059313673Adults with obesity or overweight and knee osteoarthritis (84% with BMI ≥35)445PlaceboCompletedTopline (press release)
TRANSCEND-T2D-1NCT063546603Adults with type 2 diabetes managed with diet and exercise537PlaceboCompletedPublished
TRANSCEND-T2D-2 (vs semaglutide)NCT062607223Adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor1,298Semaglutide 2 mg (Ozempic), open-labelActive, not recruitingTopline (press release)
TRIUMPH-1-OSA and TRIUMPH-2-OSA3Adults with obesity and obstructive sleep apnea (substudies of TRIUMPH-1 and TRIUMPH-2)691PlaceboCompletedPublished
Phase 2 obesity trialNCT048817602Adults with obesity, or overweight with a weight-related condition, without diabetes338PlaceboCompletedPublished
Phase 2 type 2 diabetes trialNCT048677852Adults with type 2 diabetes (HbA1c 7.0–10.5%, BMI 25–50) on diet and exercise or metformin281Placebo and dulaglutide 1.5 mgCompletedPublished
Phase 2 liver-fat substudy (MASLD)2Participants of the phase 2 obesity trial with MASLD and ≥10% liver fat98PlaceboCompletedPublished
Phase 1b multiple-dose trialNCT041438021bAdults with type 2 diabetes72Placebo and dulaglutide 1.5 mgCompletedNone yet
TRIUMPH-5 (vs tirzepatide)NCT066623833Adults with obesity800 plannedTirzepatide, double-blindActive, not recruitingNone yet
TRIUMPH-OutcomesNCT063833903Adults with BMI ≥27 and atherosclerotic cardiovascular disease and/or chronic kidney disease10,000 plannedPlaceboActive, not recruitingNone yet
TRIUMPH-6NCT068592683bAdults with obesity: maintenance of weight reduction643 plannedPlacebo (switch after week 80)Active, not recruitingNone yet
TRIUMPH-7NCT070350933Adults with obesity or overweight and chronic low back pain586 plannedPlaceboActive, not recruitingNone yet
TRIUMPH-8NCT072327193bAdults with obesity or overweight without type 2 diabetes250 plannedPlaceboActive, not recruitingNone yet
TRIUMPH-9NCT073574153bAdults with obesity or overweight without type 2 diabetes: escalation schemes600 plannedRetatrutide escalation schemes compared with each otherActive, not recruitingNone yet
TRANSCEND-T2D-3NCT062976033Adults with type 2 diabetes and moderate or severe kidney impairment on basal insulin320 plannedPlaceboActive, not recruitingNone yet
TRANSCEND-CKDNCT059361512Adults with chronic kidney disease146PlaceboCompletedNone yet
MASLD outcomes master protocolNCT071650283Adults with MASLD at increased risk of major adverse liver outcomes4,500 plannedPlacebo within each sub-protocol (retatrutide and tirzepatide sub-protocols are separate, not head-to-head)RecruitingNone yet

The weight outcomes are charted arm by arm on Retatrutide weight loss results.

Trials with reported results

Each trial is its own comparison against its own control group. Figures from different trials differ in population, duration and estimand and are not compared with each other here.

TRIUMPH-1

NCT05929066 on ClinicalTrials.gov

Phase
Phase 3
Status
Completed
Population
Adults with obesity or overweight without type 2 diabetes (with knee osteoarthritis and sleep apnea substudies)
Randomized
2,339
Duration
80 weeks (24-week extension in participants with BMI ≥35)
Comparator
Placebo
Primary endpoint
Percent change in body weight at week 80

Arms as registered or published: Retatrutide 4 mg; Retatrutide 9 mg; Retatrutide 12 mg; Placebo (1:1:1:1)

Reported results

TRIUMPH-1: Mean % change in body weight, Week 80Treatment-regimen estimand (the paper’s primary analysis)
Retatrutide 4 mg−17.6%Retatrutide 9 mg−23.7%Retatrutide 12 mg−25.0%Placebo−3.9%
TRIUMPH-1: Mean % change in body weight at Week 80, by arm
ArmReported
Retatrutide 4 mg−17.6%
Retatrutide 9 mg−23.7%
Retatrutide 12 mg−25.0%
Placebo(comparator)−3.9%

Peer-reviewed publication: Jastreboff AM, et al. N Engl J Med 2026;395:1781-1793 (TRIUMPH-1)

Adverse events reported

TRIUMPH-1: adverse events by arm
Event4 mg9 mg12 mgPlacebo
Nausea28.6%38.4%42.4%14.8%
Diarrhea25.2%34.1%32.0%13.5%
Constipation23.8%25.9%26.1%10.9%
Vomiting10.6%22.8%25.3%4.8%
Dysesthesia (altered skin sensation)5.1%12.3%12.5%0.9%
Stopped treatment because of adverse events4.1%6.9%11.3%4.9%

Percent of participants, as reported in Eli Lilly press release, 2026-05-21 (TRIUMPH-1 topline).

  • Adverse event rates are from Lilly’s 2026-05-21 topline release; Lilly’s medical-information page gives slightly different discontinuation figures from a later data cut.
  • In the 532 participants with BMI ≥35 who continued to week 104, the 12 mg arm reported −29.9% (treatment-regimen estimand) in the topline release.

Sources

TRIUMPH-2

NCT05929079 on ClinicalTrials.gov

Phase
Phase 3
Status
Completed
Population
Adults with type 2 diabetes and obesity or overweight
Randomized
1,152
Duration
80 weeks
Comparator
Placebo
Primary endpoint
Percent change in body weight at week 80

Arms as registered or published: Retatrutide 4 mg (n=292); Retatrutide 9 mg (n=284); Retatrutide 12 mg (n=287); Placebo (n=289)

Reported results

TRIUMPH-2: Mean % change in body weight, Week 80Treatment-regimen estimand
Retatrutide 4 mg−11.9%Retatrutide 9 mg−16.8%Retatrutide 12 mg−18.8%Placebo−5.1%
TRIUMPH-2: Mean % change in body weight at Week 80, by arm
ArmReportedAnalysed
Retatrutide 4 mg−11.9%n=292
Retatrutide 9 mg−16.8%n=284
Retatrutide 12 mg−18.8%n=287
Placebo(comparator)−5.1%n=289

Peer-reviewed publication: Bellido V, et al. Lancet 2026;408:1455-1472 (TRIUMPH-2)

Adverse events reported

TRIUMPH-2: adverse events by arm
Event4 mg9 mg12 mgPlacebo
Diarrhea27%34%34%13%
Nausea14%21%28%8%
Dysesthesia4%6%7%1%
Hypotension1%5%6%<1%
Stopped treatment because of adverse events or death4%12%8%5%

Percent of participants, as reported in Bellido V, et al. Lancet 2026;408:1455-1472 (TRIUMPH-2).

  • Lilly’s 2026-07-23 topline release reported the efficacy estimand instead (−20.8% at 12 mg vs −4.0% placebo) and A1C changes the abstract does not give.

TRIUMPH-3

NCT05882045 on ClinicalTrials.gov

Phase
Phase 3
Status
Completed
Population
Adults with severe obesity and established cardiovascular disease
Randomized
1,949
Duration
80 weeks
Comparator
Placebo
Primary endpoint
Percent change in body weight at week 80

Arms as registered or published: Retatrutide 9 mg; Retatrutide 12 mg; Placebo (1:1:2)

Reported results

TRIUMPH-3: Mean % change in body weight, Week 80Efficacy estimand, from Lilly’s topline release (no peer-reviewed paper yet)
Retatrutide 9 mg−21.6%Retatrutide 12 mg−22.6%Placebo−3.2%
TRIUMPH-3: Mean % change in body weight at Week 80, by arm
ArmReported
Retatrutide 9 mg−21.6%
Retatrutide 12 mg−22.6%
Placebo(comparator)−3.2%

Sponsor topline release (not peer-reviewed): Eli Lilly press release, 2026-07-23 (TRIUMPH-2 and TRIUMPH-3 topline)

Adverse events reported

TRIUMPH-3: adverse events by arm
Event9 mg12 mgPlacebo
Stopped treatment because of adverse events9.8%13.5%4.8%

Percent of participants, as reported in Eli Lilly press release, 2026-07-23 (TRIUMPH-2 and TRIUMPH-3 topline).

  • Lilly also reported in-trial cardiovascular events pooled across retatrutide arms (MACE-5 hazard ratio 0.82, 95% CI 0.55 to 1.22). This is a weight trial, events were fewer than expected and the interval includes no effect: it is not cardiovascular outcome evidence. TRIUMPH-Outcomes is the trial designed for that.

TRIUMPH-4

NCT05931367 on ClinicalTrials.gov

Phase
Phase 3
Status
Completed
Population
Adults with obesity or overweight and knee osteoarthritis (84% with BMI ≥35)
Randomized
445
Duration
68 weeks
Comparator
Placebo
Primary endpoint
WOMAC pain and percent change in body weight at week 68

Arms as registered or published: Retatrutide 9 mg; Retatrutide 12 mg; Placebo (1:1:1)

Reported results

TRIUMPH-4: Mean % change in body weight, Week 68Treatment-regimen estimand, from Lilly’s topline release (no peer-reviewed paper yet)
Retatrutide 9 mg−20.0%Retatrutide 12 mg−23.7%Placebo−4.6%
TRIUMPH-4: Mean % change in body weight at Week 68, by arm
ArmReported
Retatrutide 9 mg−20.0%
Retatrutide 12 mg−23.7%
Placebo(comparator)−4.6%

Sponsor topline release (not peer-reviewed): Eli Lilly press release, 2025-12-11 (TRIUMPH-4 topline)

Adverse events reported

TRIUMPH-4: adverse events by arm
Event9 mg12 mgPlacebo
Nausea38.1%43.2%10.7%
Diarrhea34.7%33.1%13.4%
Constipation21.8%25.0%8.7%
Vomiting20.4%20.9%0.0%
Dysesthesia8.8%20.9%0.7%
Stopped treatment because of adverse events12.2%18.2%4.0%

Percent of participants, as reported in Eli Lilly press release, 2025-12-11 (TRIUMPH-4 topline).

  • Lilly’s release gives NCT05869903 for this trial; that number belongs to a different Lilly trial (ATTAIN-1, orforglipron). The ClinicalTrials.gov record for TRIUMPH-4 is NCT05931367.
  • Mean baseline weight was 112.7 kg (BMI 40.4), heavier than in TRIUMPH-1.

Sources

TRANSCEND-T2D-1

NCT06354660 on ClinicalTrials.gov

Phase
Phase 3
Status
Completed
Population
Adults with type 2 diabetes managed with diet and exercise
Randomized
537
Duration
40 weeks
Comparator
Placebo
Primary endpoint
HbA1c change at week 40

Arms as registered or published: Retatrutide 4 mg (n=134); Retatrutide 9 mg (n=133); Retatrutide 12 mg (n=136); Placebo (n=134)

Reported results

TRANSCEND-T2D-1: Mean % change in body weight, Week 40Treatment-regimen estimand
Retatrutide 4 mg−11.5%Retatrutide 9 mg−13.9%Retatrutide 12 mg−15.3%Placebo−2.6%
TRANSCEND-T2D-1: Mean % change in body weight at Week 40, by arm
ArmReportedAnalysed
Retatrutide 4 mg−11.5%n=134
Retatrutide 9 mg−13.9%n=133
Retatrutide 12 mg−15.3%n=136
Placebo(comparator)−2.6%n=134

Peer-reviewed publication: Bajaj HS, et al. Lancet 2026;407:2402-2413 (TRANSCEND-T2D-1)

  • Stopping treatment because of adverse events was reported as 2–5% with retatrutide and 0% with placebo; no severe hypoglycemia.

TRANSCEND-T2D-2 (vs semaglutide)

NCT06260722 on ClinicalTrials.gov

Phase
Phase 3
Status
Active, not recruiting
Population
Adults with type 2 diabetes on metformin, with or without an SGLT2 inhibitor
Randomized
1,298
Duration
80 weeks
Comparator
Semaglutide 2 mg (Ozempic), open-label
Primary endpoint
HbA1c change at week 80 (noninferiority of 12 mg vs semaglutide 2 mg)

Arms as registered or published: Retatrutide 9 mg; Retatrutide 12 mg; Semaglutide (Ozempic) 2 mg (2:2:1)

Reported results

TRANSCEND-T2D-2 (vs semaglutide): Mean % change in body weight, Week 80Efficacy estimand only, from Lilly’s topline release (no peer-reviewed paper yet)
Retatrutide 9 mg−19.5%Retatrutide 12 mg−20.9%Semaglutide 2 mg−9.4%
TRANSCEND-T2D-2 (vs semaglutide): Mean % change in body weight at Week 80, by arm
ArmReported
Retatrutide 9 mg−19.5%
Retatrutide 12 mg−20.9%
Semaglutide 2 mg(comparator)−9.4%

Sponsor topline release (not peer-reviewed): Eli Lilly press release, 2026-10-28 (TRANSCEND-T2D-2 topline)

Adverse events reported

TRANSCEND-T2D-2 (vs semaglutide): adverse events by arm
Event9 mg12 mgSemaglutide 2 mg
Stopped treatment because of adverse events4.8%7.9%2.7%

Percent of participants, as reported in Eli Lilly press release, 2026-10-28 (TRANSCEND-T2D-2 topline).

  • The first randomized trial of retatrutide against another incretin medicine. It is open-label, in type 2 diabetes, and so far reported only as a press release using the efficacy estimand.
  • The registry still lists an estimated enrollment of 1,250; Lilly reports 1,298 randomized.

TRIUMPH-1-OSA and TRIUMPH-2-OSA

Phase
Phase 3
Status
Completed
Population
Adults with obesity and obstructive sleep apnea (substudies of TRIUMPH-1 and TRIUMPH-2)
Randomized
691
Duration
80 weeks
Comparator
Placebo
Primary endpoint
Change in apnea-hypopnea index (AHI) at week 80

Reported results

TRIUMPH-1-OSA and TRIUMPH-2-OSA: AHI change (TRIUMPH-1-OSA, no diabetes, n=243), Week 80Hybrid estimand
Retatrutide 4 mg−22.9 events per hourRetatrutide 9 mg−34.3 events per hourRetatrutide 12 mg−31.7 events per hourPlacebo−9.9 events per hour
TRIUMPH-1-OSA and TRIUMPH-2-OSA: AHI change (TRIUMPH-1-OSA, no diabetes, n=243) at Week 80, by arm
ArmReported
Retatrutide 4 mg−22.9 events per hour
Retatrutide 9 mg−34.3 events per hour
Retatrutide 12 mg−31.7 events per hour
Placebo(comparator)−9.9 events per hour

Peer-reviewed publication: Grunstein RR, et al. N Engl J Med 2026 (online Oct 21; TRIUMPH-1-OSA and TRIUMPH-2-OSA)

Phase 2 obesity trial

NCT04881760 on ClinicalTrials.gov

Phase
Phase 2
Status
Completed
Population
Adults with obesity, or overweight with a weight-related condition, without diabetes
Enrolled
338
Duration
48 weeks
Comparator
Placebo
Primary endpoint
Percent change in body weight at week 24

Arms as registered or published: Retatrutide 1 mg; 4 mg (two starting schemes, combined); 8 mg (two starting schemes, combined); 12 mg; Placebo

Reported results

Phase 2 obesity trial: Mean % change in body weight, Week 48Efficacy estimand (least-squares mean)
Retatrutide 1 mg−8.7%Retatrutide 4 mg−17.1%Retatrutide 8 mg−22.8%Retatrutide 12 mg−24.2%Placebo−2.1%
Phase 2 obesity trial: Mean % change in body weight at Week 48, by arm
ArmReported
Retatrutide 1 mg−8.7%
Retatrutide 4 mg−17.1%
Retatrutide 8 mg−22.8%
Retatrutide 12 mg−24.2%
Placebo(comparator)−2.1%

Peer-reviewed publication: Jastreboff AM, et al. N Engl J Med 2023;389:514-526

Adverse events reported

Phase 2 obesity trial: adverse events by arm
EventPlacebo1 mg4 mg (start 2)4 mg (start 4)8 mg (start 2)8 mg (start 4)12 mg
Nausea11%14%18%36%17%60%45%
Diarrhea11%9%12%12%20%20%15%
Vomiting1%3%12%12%6%26%19%
Constipation3%7%15%6%11%11%16%
Stopped treatment because of adverse events0%7%6%9%14%6%16%

Percent of participants, as reported in Jastreboff AM, et al. N Engl J Med 2023;389:514-526.

  • Serious adverse events occurred in 4% of both the retatrutide and placebo groups. Heart rate rose with dose, peaked at week 24 and declined afterwards.
  • Skin sensitivity (cutaneous hyperesthesia) was reported in 7% on retatrutide and 1% on placebo.
  • Starting at 2 mg rather than 4 mg partly reduced gastrointestinal events, which is why later trials escalate gradually.

Sources

Phase 2 type 2 diabetes trial

NCT04867785 on ClinicalTrials.gov

Phase
Phase 2
Status
Completed
Population
Adults with type 2 diabetes (HbA1c 7.0–10.5%, BMI 25–50) on diet and exercise or metformin
Randomized
281
Duration
36 weeks
Comparator
Placebo and dulaglutide 1.5 mg
Primary endpoint
HbA1c change at week 24

Reported results

Phase 2 type 2 diabetes trial: Mean % change in body weight, Week 36Least-squares mean, as reported in the abstract
Retatrutide 0.5 mg−3.19%Retatrutide 4 mg (escalat…−7.92%Retatrutide 4 mg−10.37%Retatrutide 8 mg (slow)−16.81%Retatrutide 8 mg (fast)−16.34%Retatrutide 12 mg−16.94%Placebo−3.0%Dulaglutide 1.5 mg−2.02%
Phase 2 type 2 diabetes trial: Mean % change in body weight at Week 36, by arm
ArmReported
Retatrutide 0.5 mg−3.19%
Retatrutide 4 mg (escalated)−7.92%
Retatrutide 4 mg−10.37%
Retatrutide 8 mg (slow)−16.81%
Retatrutide 8 mg (fast)−16.34%
Retatrutide 12 mg−16.94%
Placebo(comparator)−3.0%
Dulaglutide 1.5 mg(comparator)−2.02%

Peer-reviewed publication: Rosenstock J, et al. Lancet 2023;402:529-544

  • Mild-to-moderate gastrointestinal events: 35% on retatrutide overall (13% at 0.5 mg to 50% at 8 mg fast escalation), 13% on placebo, 35% on dulaglutide. No severe hypoglycemia and no deaths.

Sources

Phase 2 liver-fat substudy (MASLD)

Phase
Phase 2
Status
Completed
Population
Participants of the phase 2 obesity trial with MASLD and ≥10% liver fat
Randomized
98
Duration
48 weeks (primary outcome at 24 weeks)
Comparator
Placebo
Primary endpoint
Relative change in liver fat at week 24

Reported results

Phase 2 liver-fat substudy (MASLD): Relative change in liver fat, Week 24
Retatrutide 1 mg−42.9%Retatrutide 4 mg−57.0%Retatrutide 8 mg−81.4%Retatrutide 12 mg−82.4%Placebo+0.3%
Phase 2 liver-fat substudy (MASLD): Relative change in liver fat at Week 24, by arm
ArmReported
Retatrutide 1 mg−42.9%
Retatrutide 4 mg−57.0%
Retatrutide 8 mg−81.4%
Retatrutide 12 mg−82.4%
Placebo(comparator)+0.3%

Peer-reviewed publication: Sanyal AJ, et al. Nat Med 2024;30:2037-2048

Sources

Registered trials without results yet

These are registrations: what each trial plans to enroll and measure. A registration is not a result.

Phase 1b multiple-dose trial

NCT04143802 on ClinicalTrials.gov

Phase
Phase 1b
Status
Completed
Population
Adults with type 2 diabetes
Enrolled
72
Duration
12 weeks
Comparator
Placebo and dulaglutide 1.5 mg

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

  • Pharmacokinetics were dose-proportional and the half-life was approximately 6 days, which is what supports once-weekly dosing.
  • Placebo-adjusted weight change reached −8.96 kg in the highest escalation cohort over 12 weeks.

Sources

TRIUMPH-5 (vs tirzepatide)

NCT06662383 on ClinicalTrials.gov

Phase
Phase 3
Status
Active, not recruiting
Population
Adults with obesity
Planned enrollment
800
Comparator
Tirzepatide, double-blind
Primary endpoint
Percent change in body weight at week 80
Primary completion
November 2026 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

  • The only registered randomized comparison of retatrutide with tirzepatide.

TRIUMPH-Outcomes

NCT06383390 on ClinicalTrials.gov

Phase
Phase 3
Status
Active, not recruiting
Population
Adults with BMI ≥27 and atherosclerotic cardiovascular disease and/or chronic kidney disease
Planned enrollment
10,000
Comparator
Placebo
Primary endpoint
Time to first major adverse cardiovascular event; time to first kidney composite event
Primary completion
February 2029 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

TRIUMPH-6

NCT06859268 on ClinicalTrials.gov

Phase
Phase 3b
Status
Active, not recruiting
Population
Adults with obesity: maintenance of weight reduction
Planned enrollment
643
Comparator
Placebo (switch after week 80)
Primary endpoint
Percent change in body weight from week 0 to week 116
Primary completion
April 2028 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

TRIUMPH-7

NCT07035093 on ClinicalTrials.gov

Phase
Phase 3
Status
Active, not recruiting
Population
Adults with obesity or overweight and chronic low back pain
Planned enrollment
586
Comparator
Placebo
Primary endpoint
Pain score change and percent change in body weight, up to 72 weeks
Primary completion
September 2027 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

TRIUMPH-8

NCT07232719 on ClinicalTrials.gov

Phase
Phase 3b
Status
Active, not recruiting
Population
Adults with obesity or overweight without type 2 diabetes
Planned enrollment
250
Comparator
Placebo
Primary endpoint
Percent change in body weight at week 56
Primary completion
July 2027 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

TRIUMPH-9

NCT07357415 on ClinicalTrials.gov

Phase
Phase 3b
Status
Active, not recruiting
Population
Adults with obesity or overweight without type 2 diabetes: escalation schemes
Planned enrollment
600
Comparator
Retatrutide escalation schemes compared with each other
Primary endpoint
Percent change in body weight at week 104
Primary completion
October 2028 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

TRANSCEND-T2D-3

NCT06297603 on ClinicalTrials.gov

Phase
Phase 3
Status
Active, not recruiting
Population
Adults with type 2 diabetes and moderate or severe kidney impairment on basal insulin
Planned enrollment
320
Comparator
Placebo
Primary endpoint
HbA1c change at week 52
Primary completion
October 2026 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

TRANSCEND-CKD

NCT05936151 on ClinicalTrials.gov

Phase
Phase 2
Status
Completed
Population
Adults with chronic kidney disease
Randomized
146
Comparator
Placebo
Primary endpoint
Change in measured glomerular filtration rate at week 24
Primary completion
October 2025 (actual)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

  • Completed, but only the design and baseline paper has been published; no results yet.

MASLD outcomes master protocol

NCT07165028 on ClinicalTrials.gov

Phase
Phase 3
Status
Recruiting
Population
Adults with MASLD at increased risk of major adverse liver outcomes
Planned enrollment
4,500
Comparator
Placebo within each sub-protocol (retatrutide and tirzepatide sub-protocols are separate, not head-to-head)
Primary endpoint
Time to first major adverse liver outcome
Primary completion
August 2030 (estimated)

Reported results

No results have been reported yet. Registration details describe what the trial plans to measure, not an outcome.

Evidence quality

Peptide Library grades human evidence claim by claim with risk-of-bias tools and GRADE, published only from frozen assessments. Retatrutide has not been assessed under that method yet, which is not evidence either way. Until it is, read each trial for its design: randomized and placebo-controlled, its size and duration, and whether the figure comes from a peer-reviewed paper or a sponsor’s topline release.

How the evidence-quality method works · Retatrutide publication and trial statistics

What the trials do not answer yet

  • Cardiovascular and kidney outcomes: TRIUMPH-Outcomes (about 10,000 participants) is not expected to finish before 2029.
  • Long-term safety beyond 80–104 weeks, and rare adverse events that only a larger exposed population can show.
  • A blinded comparison with tirzepatide (TRIUMPH-5) and a peer-reviewed report of the semaglutide comparison.
  • What happens to weight after treatment stops, which TRIUMPH-6 is designed to test.
  • Dysesthesia (altered skin sensation) and heart-rate increases, both reported more often than with placebo and not yet fully characterized.

Regulatory status sources