{"format":"citation-manifest/v1","page":"https://retatrutidebio.com/monograph","claim_count":68,"claims":[{"id":"RETA-001","text":"Retatrutide, developed by Eli Lilly under the code LY3437943, is a single peptide with agonist activity at three receptors: glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon.","source_url":"https://europepmc.org/article/MED/37366315","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"RETA-002","text":"PubChem maps deposited retatrutide substance records to compound CID 171390338, with molecular formula C221H342N46O68 and molecular weight approximately 4731 g/mol; the synonym list for this CID includes the nickname Triple G.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/171390338","grade":"chemical-reference","grade_label":"Chemical reference"},{"id":"RETA-003","text":"A Drugs@FDA search for retatrutide as an active ingredient returns zero records: no retatrutide product has ever been approved by FDA for any use.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"RETA-004","text":"FDA states that retatrutide cannot be used in compounding under federal law, is not a component of any FDA-approved drug, and has not been found safe and effective for any condition.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record"},{"id":"RETA-005","text":"FDA has warned telehealth companies for marketing unapproved drugs such as retatrutide including direct marketing to consumers, active pharmaceutical ingredient distributors for selling retatrutide to compounders, and outsourcing facilities for repackaging retatrutide.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record"},{"id":"RETA-006","text":"FDA has warned companies that illegally sold unapproved drugs containing retatrutide falsely labeled 'for research purposes' or 'not for human consumption'; FDA notes these products have been sold directly to consumers for human use, with dosing instructions.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record"},{"id":"RETA-007","text":"FDA warns that illegally marketed GLP-1 class drugs may be counterfeit and could contain the wrong ingredients, harmful ingredients, or too little, too much, or no active ingredient at all, and urges purchasing only from state-licensed pharmacies.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss","grade":"regulatory","grade_label":"Regulatory record"},{"id":"RETA-008","text":"Retatrutide is an investigational drug still in clinical trials. It is not FDA approved for any use; vials sold online are unapproved research chemicals.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/","grade":"regulatory","grade_label":"Regulatory record"},{"id":"RETA-009","text":"ClinicalTrials.gov lists a pre-approval expanded access record for retatrutide (NCT07629401), posted by Eli Lilly with overall status Available, for obesity and obesity-related complications.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT07629401","grade":"registry","grade_label":"Registry record"},{"id":"RETA-010","text":"In August 2026 The BMJ reported that retatrutide had been opened to 'compassionate use' in the US, in a news article indexed on PubMed.","source_url":"https://europepmc.org/article/MED/42567543","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"RETA-011","text":"The retatrutide phase 2 obesity trial (NCT04881760) was a double-blind, randomized, placebo-controlled trial in 338 adults with a BMI of 30 or higher, or 27 to under 30 plus at least one weight-related condition, testing once-weekly subcutaneous retatrutide for 48 weeks; the primary endpoint was percentage weight change at 24 weeks.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-012","text":"At 24 weeks (the primary endpoint), least-squares mean weight change was -7.2% (1 mg), -12.9% (combined 4 mg), -17.3% (combined 8 mg), and -17.5% (12 mg) with retatrutide, versus -1.6% with placebo.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-013","text":"At 48 weeks, least-squares mean weight change was -8.7% (1 mg), -17.1% (combined 4 mg), -22.8% (combined 8 mg), and -24.2% (12 mg) with retatrutide, versus -2.1% with placebo.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-014","text":"At 48 weeks in the phase 2 obesity trial, weight reductions of 5% or more, 10% or more, and 15% or more occurred in 92%, 75%, and 60% of participants on 4 mg; 100%, 91%, and 75% on 8 mg; 100%, 93%, and 83% on 12 mg; versus 27%, 9%, and 2% on placebo.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-015","text":"In the phase 2 obesity trial the most common adverse events with retatrutide were gastrointestinal; they were dose-related, mostly mild to moderate in severity, and partially mitigated by a lower (2 mg versus 4 mg) starting dose.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-016","text":"In the phase 2 obesity trial, dose-dependent increases in heart rate peaked at 24 weeks of retatrutide treatment and declined thereafter.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-017","text":"The phase 2 obesity trial record NCT04881760 (start 2021-05-20, actual enrollment 338) is completed with results posted to the registry.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT04881760","grade":"registry","grade_label":"Registry record"},{"id":"RETA-018","text":"The retatrutide phase 2 type 2 diabetes trial (NCT04867785) randomized 281 adults with type 2 diabetes (HbA1c 7.0-10.5%, BMI 25-50) to placebo, dulaglutide 1.5 mg, or retatrutide 0.5 to 12 mg once weekly; the primary endpoint was HbA1c change at 24 weeks, with 36-week secondary endpoints.","source_url":"https://europepmc.org/article/MED/37385280","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-019","text":"At 24 weeks in the phase 2 diabetes trial, HbA1c fell by up to 2.02 percentage points (12 mg) versus 0.01 with placebo and 1.41 with dulaglutide 1.5 mg; retatrutide beat placebo at all doses above 0.5 mg and beat dulaglutide at the 8 mg slow-escalation and 12 mg doses.","source_url":"https://europepmc.org/article/MED/37385280","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-020","text":"At 36 weeks in the phase 2 diabetes trial, body weight decreased dose dependently by up to 16.94% (12 mg) with retatrutide, versus 3.00% with placebo and 2.02% with dulaglutide 1.5 mg.","source_url":"https://europepmc.org/article/MED/37385280","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-021","text":"In the phase 2 diabetes trial, mild-to-moderate gastrointestinal adverse events were reported in 35% of retatrutide participants overall (13% to 50% by group) versus 13% on placebo and 35% on dulaglutide; there were no reports of severe hypoglycaemia and no deaths.","source_url":"https://europepmc.org/article/MED/37385280","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-022","text":"TRANSCEND-T2D-1 (NCT06354660), published in The Lancet in June 2026, was a 40-week, phase 3, randomized, double-blind, placebo-controlled monotherapy trial of retatrutide 4, 9, or 12 mg weekly in 537 adults with type 2 diabetes inadequately controlled by diet and exercise.","source_url":"https://europepmc.org/article/MED/42250575","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-023","text":"In TRANSCEND-T2D-1, HbA1c fell 1.69 (4 mg), 1.86 (9 mg), and 1.94 (12 mg) percentage points versus 0.81 with placebo at 40 weeks; estimated treatment differences versus placebo were 0.88 to 1.12 points, all p<0.0001.","source_url":"https://europepmc.org/article/MED/42250575","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-024","text":"In TRANSCEND-T2D-1, mean body weight fell 11.5% (4 mg), 13.9% (9 mg), and 15.3% (12 mg) versus 2.6% with placebo at 40 weeks.","source_url":"https://europepmc.org/article/MED/42250575","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-025","text":"In TRANSCEND-T2D-1 the most frequent adverse events were generally mild to moderate gastrointestinal events that subsided over time; discontinuations due to adverse events were 2 to 5% with retatrutide versus 0% with placebo; no severe hypoglycaemia was reported; two deaths occurred, both in the 4 mg group and judged unrelated to study drug.","source_url":"https://europepmc.org/article/MED/42250575","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-026","text":"As of 2026-08-14, TRANSCEND-T2D-1 is the only retatrutide phase 3 trial with results published in a PubMed-indexed journal; a PubMed search for retatrutide or LY3437943 returned 171 records and contained no other phase 3 results publication.","source_url":"https://europepmc.org/article/MED/42250575","grade":"derived","grade_label":"Derived from cited data"},{"id":"RETA-027","text":"A randomized, double-blind, placebo-controlled phase 2a substudy of the obesity trial enrolled 98 participants with metabolic dysfunction-associated steatotic liver disease and at least 10% liver fat, assigned to 48 weeks of once-weekly retatrutide (1, 4, 8, or 12 mg) or placebo; the primary objective was mean relative change in liver fat at 24 weeks.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11271400/","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-028","text":"In the MASLD substudy, mean relative liver fat change at 24 weeks was -42.9% (1 mg), -57.0% (4 mg), -81.4% (8 mg), and -82.4% (12 mg) versus +0.3% with placebo (all p<0.001).","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11271400/","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-029","text":"In the MASLD substudy, normal liver fat (below 5%) was reached at 24 weeks by 27% (1 mg), 52% (4 mg), 79% (8 mg), and 86% (12 mg) of retatrutide participants, versus 0% on placebo.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11271400/","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-030","text":"In a DXA body-composition substudy of the phase 2 diabetes trial (189 enrolled), total body fat mass fell 26.1% (pooled 8 mg) and 23.2% (12 mg) with retatrutide at 36 weeks, versus 2.6% with dulaglutide 1.5 mg and 4.5% with placebo.","source_url":"https://europepmc.org/article/MED/40609566","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-031","text":"The body-composition substudy authors reported that the proportion of lean mass loss to weight loss with retatrutide was similar to other obesity treatments.","source_url":"https://europepmc.org/article/MED/40609566","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-032","text":"In a post hoc analysis of both phase 2 trials, retatrutide 12 mg reduced urine albumin-to-creatinine ratio versus placebo by 37.0% at 36 weeks in type 2 diabetes, and by 31.5% (12 mg) and 28.0% (8 mg) at 48 weeks in overweight or obesity.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12231004/","grade":"human-trial","grade_label":"Human trial"},{"id":"RETA-033","text":"In the same post hoc analysis, creatinine-derived eGFR increased with retatrutide versus placebo in participants with obesity (by 5.3 and 8.5 ml/min per 1.73 m2 at 8 and 12 mg) but was unchanged in participants with type 2 diabetes.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12231004/","grade":"human-trial","grade_label":"Human trial"},{"id":"RETA-034","text":"In the phase 1b multiple-ascending-dose trial, retatrutide pharmacokinetics were dose proportional and its half-life was approximately 6 days, supporting once-weekly dosing.","source_url":"https://europepmc.org/article/MED/36354040","grade":"human-pk","grade_label":"Human PK"},{"id":"RETA-035","text":"In the 12-week phase 1b trial in type 2 diabetes (72 participants), placebo-adjusted daily plasma glucose fell significantly at the three highest doses, and placebo-adjusted weight reduction was dose dependent, up to 8.96 kg in the highest-dose group.","source_url":"https://europepmc.org/article/MED/36354040","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-036","text":"In the phase 1b trial, treatment-emergent adverse events were reported by 63% of retatrutide recipients versus 54% on placebo, with gastrointestinal disorders most frequent.","source_url":"https://europepmc.org/article/MED/36354040","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-037","text":"In vitro, retatrutide shows balanced glucagon-receptor and GLP-1-receptor activity but greater GIP-receptor activity.","source_url":"https://europepmc.org/article/MED/35985340","grade":"in-vitro","grade_label":"In vitro"},{"id":"RETA-038","text":"In obese mice, retatrutide decreased body weight and improved glycemic control; weight loss was augmented by glucagon-receptor-mediated increases in energy expenditure on top of GIP- and GLP-1-receptor-driven reductions in calorie intake.","source_url":"https://europepmc.org/article/MED/35985340","grade":"animal","grade_label":"Animal"},{"id":"RETA-039","text":"In the phase 1 single-ascending-dose study, retatrutide showed a safety and tolerability profile similar to other incretins, and a reduction in body weight persisted up to day 43 after a single dose.","source_url":"https://europepmc.org/article/MED/35985340","grade":"human-trial","grade_label":"Human trial"},{"id":"RETA-040","text":"A 2023 brief report by Lilly scientists in Diabetes, Obesity and Metabolism is titled 'The novel GIP, GLP-1 and glucagon receptor agonist retatrutide delays gastric emptying'.","source_url":"https://europepmc.org/article/MED/37311727","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"RETA-041","text":"Cryo-EM structural analyses of retatrutide engaging all three of its receptors (GLP-1R, GIPR, GCGR) were published in Cell Discovery in 2024.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11255275/","grade":"in-vitro","grade_label":"In vitro"},{"id":"RETA-042","text":"A 2026 IUPHAR review states that glucagon-receptor agonism has been combined with GLP-1R and GLP-1R/GIPR agonism for improved body weight loss via energy expenditure stimulation, and that mechanistic evidence for glucagon-receptor action is largely preclinical, with clinical data extremely limited.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12910462/","grade":"review","grade_label":"Review or guideline"},{"id":"RETA-043","text":"In prespecified exploratory analyses of the phase 2 diabetes trial, participants on retatrutide 4 mg or higher reported greater reductions in overall appetite, hunger, and prospective food consumption than placebo at week 24, and reductions in perceived hunger and disinhibition correlated with weight reduction.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12587234/","grade":"human-trial","grade_label":"Human trial"},{"id":"RETA-044","text":"A phase 1 trial measuring the effect of retatrutide versus placebo on calorie intake and energy expenditure in participants with obesity (NCT06313528, 85 participants) completed in August 2025; no results have been posted to the registry.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06313528","grade":"registry","grade_label":"Registry record"},{"id":"RETA-045","text":"A 2025 systematic review and meta-analysis pooling four randomized controlled trials found dose-dependent effects of retatrutide, with the 12 mg dose producing the maximum reductions across outcomes and a safety profile comparable to control.","source_url":"https://europepmc.org/article/MED/39817343","grade":"review","grade_label":"Review or guideline"},{"id":"RETA-046","text":"A 2026 meta-analysis of randomized trials found retatrutide reduced systolic blood pressure by 6.79 mmHg and diastolic by 2.46 mmHg, lowered total cholesterol by 21.88 mg/dL, LDL-C by 13.10 mg/dL, and triglycerides by 40.90 mg/dL, with no significant HDL-C change.","source_url":"https://europepmc.org/article/MED/42371360","grade":"review","grade_label":"Review or guideline"},{"id":"RETA-047","text":"A 2025 Bayesian network meta-analysis of 19 randomized trials (29,506 adults) reported retatrutide had the highest odds of 15% or greater weight loss (odds ratio 54.6) among the compared incretin drug classes, and also the highest adverse-event risk.","source_url":"https://europepmc.org/article/MED/40685589","grade":"review","grade_label":"Review or guideline"},{"id":"RETA-048","text":"A 2026 pharmacovigilance analysis of the WHO VigiBase database concluded that its data strengthen evidence for dysesthesias (abnormal skin sensations, including burning) associated with GLP-1-receptor-agonist therapies, describing such events as dose-dependent and as already observed in clinical trials of semaglutide, tirzepatide, and retatrutide; discontinuation was often followed by spontaneous favorable outcomes.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13194321/","grade":"review","grade_label":"Review or guideline"},{"id":"RETA-049","text":"In SURMOUNT-1 (phase 3, 2,539 adults, 72 weeks), tirzepatide produced mean weight changes of -15.0% (5 mg), -19.5% (10 mg), and -20.9% (15 mg) versus -3.1% with placebo.","source_url":"https://europepmc.org/article/MED/35658024","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-051","text":"In SELECT (17,604 patients with cardiovascular disease and overweight or obesity, no diabetes), semaglutide 2.4 mg reduced major adverse cardiovascular events versus placebo (6.5% vs 8.0%; hazard ratio 0.80, p<0.001) over a mean 39.8 months.","source_url":"https://europepmc.org/article/MED/37952131","grade":"human-rct","grade_label":"Human RCT"},{"id":"RETA-052","text":"Retatrutide's 24.2% mean reduction is a 48-week phase 2 result in 338 people; it is numerically larger than the best published phase 3 means for the approved incretin drugs (tirzepatide 20.9% at 72 weeks; semaglutide 14.9% at 68 weeks), but these are different trials, phases, durations, and populations, and no head-to-head results exist.","source_url":"https://europepmc.org/article/MED/37366315","grade":"derived","grade_label":"Derived from cited data"},{"id":"RETA-053","text":"The TRIUMPH registrational program's design paper describes four phase 3, multicenter, randomized, double-blind trials of weekly retatrutide versus placebo in over 5,800 participants, using a basket design that nests obstructive sleep apnea and knee osteoarthritis protocols inside the weight-management trials.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12673447/","grade":"review","grade_label":"Review or guideline"},{"id":"RETA-054","text":"TRIUMPH-1 (NCT05929066), the phase 3 trial of retatrutide in obesity or overweight without diabetes (with nested OSA and knee-OA baskets), enrolled 2,335 participants; the registry lists it as completed with actual primary completion April 6, 2026, and no posted results.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT05929066","grade":"registry","grade_label":"Registry record"},{"id":"RETA-055","text":"TRIUMPH-2 (NCT05929079), the phase 3 trial in type 2 diabetes with obesity or overweight, enrolled 1,152 participants and is listed as completed (actual primary completion June 16, 2026) with no posted results.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT05929079","grade":"registry","grade_label":"Registry record"},{"id":"RETA-056","text":"TRIUMPH-3 (NCT05882045), the phase 3 trial in severe obesity with established cardiovascular disease, enrolled 1,946 participants and is listed as completed (actual primary completion April 16, 2026) with no posted results.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT05882045","grade":"registry","grade_label":"Registry record"},{"id":"RETA-057","text":"TRIUMPH-4 (NCT05931367), the phase 3 trial in obesity or overweight with knee osteoarthritis, enrolled 445 participants and is listed as completed (actual primary completion November 14, 2025) with no posted results.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT05931367","grade":"registry","grade_label":"Registry record"},{"id":"RETA-058","text":"TRIUMPH-5 (NCT06662383) is a phase 3, randomized, double-blind head-to-head trial of retatrutide versus tirzepatide in adults with obesity (about 800 participants), active and not recruiting, with estimated primary completion in November 2026 and no posted results.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06662383","grade":"registry","grade_label":"Registry record"},{"id":"RETA-059","text":"TRIUMPH-6 (NCT06859268) is a phase 3b, randomized, double-blind, placebo-controlled trial of retatrutide in the maintenance of weight reduction (about 643 participants), with estimated primary completion in April 2028.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06859268","grade":"registry","grade_label":"Registry record"},{"id":"RETA-060","text":"TRIUMPH-7 (NCT07035093) is a phase 3 trial of retatrutide in obesity or overweight with chronic low back pain (about 586 participants), with estimated primary completion in September 2027; TRIUMPH-8 (NCT07232719, about 250 participants, est. July 2027) and TRIUMPH-9 (NCT07357415, about 600 participants, dose-escalation schemes, est. October 2028) are additional phase 3b obesity trials.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT07035093","grade":"registry","grade_label":"Registry record"},{"id":"RETA-061","text":"TRIUMPH-Outcomes (NCT06383390) is a phase 3, randomized, double-blind, placebo-controlled, event-driven trial of retatrutide on the incidence of major adverse cardiovascular events in adults with atherosclerotic cardiovascular disease and/or chronic kidney disease, with an estimated 10,000 participants and estimated primary completion in February 2029.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06383390","grade":"registry","grade_label":"Registry record"},{"id":"RETA-062","text":"Beyond TRANSCEND-T2D-1, the registry lists further phase 3 type 2 diabetes trials of retatrutide: an open-label head-to-head versus semaglutide (NCT06260722, about 1,250 participants, estimated primary completion August 2026) and a placebo-controlled trial in type 2 diabetes with moderate or severe chronic kidney disease (NCT06297603, about 320 participants, estimated primary completion October 2026); neither has posted results.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06260722","grade":"registry","grade_label":"Registry record"},{"id":"RETA-063","text":"TRANSCEND-CKD (NCT05936151) is a phase 2b mechanistic, double-blind, placebo-controlled trial of retatrutide in 146 randomized adults with overweight or obesity and chronic kidney disease (eGFR 25-75), with measured GFR by iohexol clearance at week 24 as primary objective; it is designed to inform the TRIUMPH-Outcomes trial, and the registry lists actual primary completion October 1, 2025 with no posted results.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13218929/","grade":"human-trial","grade_label":"Human trial"},{"id":"RETA-064","text":"A phase 3 master-protocol trial including retatrutide in metabolic dysfunction-associated steatotic liver disease (NCT07165028, about 4,500 participants) is recruiting, with estimated primary completion in August 2030.","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT07165028","grade":"registry","grade_label":"Registry record"},{"id":"RETA-065","text":"As of the 2026-08-13 registry snapshot re-verified 2026-08-14, ClinicalTrials.gov holds 33 retatrutide study records; 14 are phase 3 records with combined enrollment (actual or estimated) of 25,364 participants, and zero of the 14 phase 3 records have posted results. The only records with posted results are the two phase 2 trials.","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=retatrutide","grade":"derived","grade_label":"Derived from cited data"},{"id":"RETA-066","text":"A 2026 peer-reviewed letter in Drug and Alcohol Review reports on the composition and labelling accuracy of products sold as retatrutide in Australia, documenting that gray-market retatrutide products are being formally tested.","source_url":"https://europepmc.org/article/MED/42559975","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"RETA-067","text":"In July 2026 The BMJ published a fact check examining the question of whether a man died after taking retatrutide bought as an unapproved weight loss injection.","source_url":"https://europepmc.org/article/MED/42425580","grade":"bibliographic","grade_label":"Bibliographic record"},{"id":"RETA-068","text":"There is no FDA prescribing label for retatrutide: no approved indications, no approved dose, no contraindications section, and no official safety information exist; everything known about who was studied comes from trial eligibility criteria.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/","grade":"derived","grade_label":"Derived from cited data"},{"id":"RETA-069","text":"Published retatrutide trials enrolled adults only, under protocol-defined entry criteria: the phase 2 obesity trial required BMI 30 or higher (or 27 to under 30 with a weight-related condition); the phase 2 diabetes trial required HbA1c 7.0-10.5% and BMI 25-50; TRANSCEND-T2D-1 required HbA1c 7.0-9.5% and BMI 23 or higher.","source_url":"https://europepmc.org/article/MED/37366315","grade":"human-rct","grade_label":"Human RCT"}]}