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Retatrutide side effects: what trials and regulators have recorded

In the 80-week TRIUMPH-2 trial of 1,152 adults with type 2 diabetes, funded by the developer, gut effects were the most common side effects: diarrhoea affected 27% to 34% of people across the three retatrutide arms against 13% on placebo, and nausea 14% to 28% against 8%, a result for that trial population only (Bellido et al., The Lancet, 2026). The TGA reported on 14 September 2026 that retatrutide is not approved by the TGA or a comparable international regulator, so no approved label from those regulators lists its side effects.

Published 2026-10-14Updated 2026-10-14Written by Form Laboratories research team12 min read

Every medicine you have ever taken came with a leaflet that listed what went wrong for some people. Retatrutide has no leaflet, because the TGA reports that no comparable regulator has approved it. What exists instead is a scattered record of trial papers, registry tables and regulator alerts, and each piece covers only part of the picture.

This page is part of the retatrutide hub. It collects what those records say about retatrutide's side effects, with the study, the size and the comparison group beside each figure. Efficacy results sit on the study findings page. Nothing here is medical advice, and it describes records, not any one person's experience.

Key facts

Key facts for Retatrutide side effects: what trials and regulators have recorded
Common nameretatrutide
Research codeLY3437943
Most frequent side effects in TRIUMPH-2gut effects: nausea, diarrhoea, vomiting, constipation (1,152 adults with type 2 diabetes; developer-funded; describes that trial only; Bellido et al., The Lancet, 2026)
TRIUMPH-2 diarrhoea27% to 34% across three retatrutide arms against 13% on placebo (1,152 adults with type 2 diabetes; developer-funded; describes that trial only; Bellido et al., The Lancet, 2026)
TRIUMPH-2 nausea14% to 28% across three retatrutide arms against 8% on placebo (1,152 adults with type 2 diabetes; developer-funded; describes that trial only; Bellido et al., The Lancet, 2026)
TRIUMPH-2 altered skin sensation (dysaesthesia)4% to 7% against 1% on placebo (1,152 adults with type 2 diabetes; developer-funded; describes that trial only; Bellido et al., The Lancet, 2026)
TRIUMPH-2 stopped treatment because of side effects or death4%, 12% and 8% across the retatrutide arms against 5% on placebo (1,152 adults with type 2 diabetes; developer-funded; describes that trial only; Bellido et al., The Lancet, 2026)
Phase 2 obesity trial, serious events10 of 267 retatrutide participants and 3 of 70 on placebo (338 adults; small developer-funded trial that cannot show rare events; ClinicalTrials.gov NCT04881760)
Regulator status as of 14 October 2026Not approved by the TGA or a comparable international regulator (TGA safety alert, 14 September 2026)
TGA test of one product sold as retatrutideundeclared semaglutide and no retatrutide in that one product, a single sample that does not show how common mislabelled products are (TGA safety alert, 14 September 2026)
Victorian health alert, 19 June 2026six reported cases of acute liver injury in people who had used products labelled retatrutide; a contaminant is suspected, not confirmed, and case reports cannot show how common the injury is (Victorian health alert, 19 June 2026)
Records checked14 October 2026
ClinicalTrials.gov NCT04881760The Lancet 2026 (TRIUMPH-2)NEJM 2023The Lancet 2023

What are the side effects of retatrutide?

In the Phase 2 obesity trial of 338 adults, funded by the developer, the registry lists gut events most often: nausea in 83 of 267 retatrutide participants (31%) against 8 of 70 on placebo (11%), vomiting in 33 (12%) against 1 (1%), diarrhoea in 37 (14%) against 8 (11%) and constipation in 30 (11%) against 2 (3%), counting only events reported by 5% or more of people in any arm of one small trial (ClinicalTrials.gov NCT04881760). In the 80-week TRIUMPH-2 trial of 1,152 adults with type 2 diabetes, also funded by the developer, nausea affected 14% to 28% of people across the three retatrutide arms against 8% on placebo, a result for that trial population only (Bellido et al., The Lancet, 2026).

In the Phase 2 obesity paper of 338 adults, funded by the developer, the most common adverse events were gut events, they grew with the trial arm level and they were mostly mild to moderate, a description of that trial population only (Jastreboff et al., New England Journal of Medicine, 2023). In the Phase 2 trial of 281 adults with type 2 diabetes, mild to moderate gut events affected 67 of 190 retatrutide participants (35%) against 6 of 45 on placebo (13%), a small early-phase result funded by the developer (Rosenstock et al., The Lancet, 2023).

The table below sets out the Phase 2 registry events side by side. The registry lists events reported by 5% or more of people in any arm, so rarer events do not appear. The pooled counts add the arm counts that the registry reports. For the same question about an approved medicine, tirzepatide's side effects are set out the same way.

TGA safety alert, 14 September 2026NEJM 2026 (TRIUMPH-1)The Lancet 2026 (TRIUMPH-2)

Evidence limits

Is retatrutide safe?

No trial or regulator gives retatrutide a yes-or-no safety verdict. The TGA reported on 14 September 2026 that retatrutide is not approved by the TGA or a comparable international regulator, so this page found no approved label from those regulators (TGA safety alert, 14 September 2026). The longest obesity trial papers read for this page ran 80 weeks (Jastreboff et al., New England Journal of Medicine, 2026; Bellido et al., The Lancet, 2026). Trials of this size count common side effects well and can miss rare ones. Eli Lilly funded and sponsored every trial cited on this page.

Two limits shape every number below. The 2026 Phase 3 papers were read as abstracts only, so their full side-effect tables are not reported here. A trial result also describes trial drug product given under supervision, not a product from any other source.

The last section of this page reports a different kind of record. Regulator alerts and case reports describe products sold as retatrutide, and they cannot give a frequency. They sit apart from the trial figures for that reason.

ClinicalTrials.gov NCT04881760The Lancet 2026 (TRIUMPH-2)The Lancet 2026 (TRANSCEND-T2D-1)The Lancet 2023

What serious events have retatrutide trials recorded?

In the Phase 2 obesity trial of 338 adults, the registry lists serious adverse events in 10 of 267 retatrutide participants (4%) and 3 of 70 on placebo (4%), with one death in a retatrutide arm, a small developer-funded trial that cannot show rare events or establish safety (ClinicalTrials.gov NCT04881760). In the Phase 2 obesity trial of 338 adults, the registry lists one case of acute pancreatitis in the highest arm, one of acute cholecystitis (gallbladder inflammation) and one of acute kidney injury, counts too small to show how often such events occur (ClinicalTrials.gov NCT04881760). In TRIUMPH-2, a developer-funded trial of 1,152 adults with type 2 diabetes, seven participants died, six on retatrutide and one on placebo, and the investigators judged every death unrelated to the study intervention (Bellido et al., The Lancet, 2026).

In TRANSCEND-T2D-1, a 40-week developer-funded trial of 537 adults with type 2 diabetes, two deaths were reported, both in the lowest retatrutide arm and judged unrelated to the study drug by the investigators, with no severe hypoglycaemia (Bajaj et al., The Lancet, 2026). The Phase 2 trial of 281 adults with type 2 diabetes reported no deaths and no severe hypoglycaemia, a short early-phase result that cannot show rare events (Rosenstock et al., The Lancet, 2023).

In the Phase 2 obesity trial of 338 adults, the registry lists increased lipase in 15 of 267 retatrutide participants against 2 of 70 on placebo, and increased amylase in 5 against 2, and those are blood-test results that do not establish pancreatitis because the registry does not say how many involved symptoms (ClinicalTrials.gov NCT04881760).

NEJM 2023The Lancet 2026 (TRIUMPH-2)ClinicalTrials.gov NCT04881760European Journal of Clinical Pharmacology 2026Kidney International Reports 2025

What risks have retatrutide studies recorded besides gut effects?

The Phase 2 obesity paper reports heart-rate increases that grew with the trial arm level, peaked at 24 weeks and declined afterwards in its 338 adults, in a developer-funded trial that describes that population only (Jastreboff et al., New England Journal of Medicine, 2023). In TRIUMPH-2, a developer-funded trial of 1,152 adults with type 2 diabetes, hypotension (low blood pressure) affected 1%, 5% and 6% of people across the retatrutide arms against under 1% on placebo, and dysaesthesia (altered or burning skin sensation) affected 4%, 6% and 7% against 1%, results for that trial population only (Bellido et al., The Lancet, 2026).

In the Phase 2 obesity trial of 338 adults, the registry lists hypertension in 14 of 267 retatrutide participants against 2 of 70 on placebo, hypotension in 6 against 0, hyperaesthesia (raised skin sensitivity) in 7 against 1, and allodynia (pain from a light touch) in 4 against 0, counting only events reported by 5% or more of people in any arm (ClinicalTrials.gov NCT04881760).

A 2026 pharmacovigilance analysis examined spontaneous reports of dysaesthesia in the VigiBase safety database and in French pharmacovigilance case narratives, with a literature review; its abstract gives no report count, its report analysis covered approved GLP-1 receptor agonists and tirzepatide rather than retatrutide, and spontaneous reports cannot give a frequency or prove cause (Laroche et al., European Journal of Clinical Pharmacology, 2026). On the kidneys, a post hoc analysis of the two Phase 2 trials (281 adults with type 2 diabetes and 338 with overweight or obesity), run after the trials by authors including developer employees, found eGFR (a kidney filtering measure) unchanged in people with type 2 diabetes and higher in people with obesity (Heerspink et al., Kidney International Reports, 2025). The hair-loss question is covered on the study findings page.

The Lancet 2026 (TRIUMPH-2)The Lancet 2026 (TRANSCEND-T2D-1)ClinicalTrials.gov NCT04881760

How many people stopped retatrutide trials because of side effects?

In the 80-week TRIUMPH-2 trial of 1,152 adults with type 2 diabetes, permanent discontinuation because of an adverse event or death was 4%, 12% and 8% across the three retatrutide arms against 5% on placebo, a result for that developer-funded trial only (Bellido et al., The Lancet, 2026). In TRANSCEND-T2D-1, a 40-week trial of 537 adults with type 2 diabetes, discontinuations because of adverse events were 2% to 5% with retatrutide and 0% with placebo, counted differently from TRIUMPH-2 and so not comparable with it (Bajaj et al., The Lancet, 2026). The Phase 2 obesity registry lists an adverse event as the reason for leaving the study for 6 retatrutide participants and none on placebo, in a small developer-funded trial of 338 adults that cannot show how often rarer events lead to stopping (ClinicalTrials.gov NCT04881760).

The counts differ between trials because the trials differ in length, population and the rules for counting. TRIUMPH-2 combined adverse events and deaths into one measure, and TRANSCEND-T2D-1 counted adverse events alone (Bellido et al., The Lancet, 2026; Bajaj et al., The Lancet, 2026). A percentage only means something while it stays attached to the trial that produced it.

TGA safety alert, 14 September 2026Victorian health alert, 19 June 2026Drug and Alcohol Review 2026BMJ Case Reports 2026

What have Australian authorities reported about products sold as retatrutide?

Australian authorities have issued two warnings about products sold as retatrutide. On 14 September 2026 the TGA reported that one consumer had uncontrollable vomiting that tore the oesophagus and needed hospital care, and that laboratory testing of the unmarked vial found undeclared semaglutide at about eight times the level in semaglutide products on the Australian Register of Therapeutic Goods, and no retatrutide, a report about one person and one sample that does not show how common such events are (TGA safety alert, 14 September 2026). On 19 June 2026 the Victorian Chief Health Officer reported six cases of acute liver injury since January 2026 in people who had used products labelled retatrutide, possibly linked to a contaminant, in an alert about case reports in which the cause was not established (Victorian health alert, 19 June 2026).

A 2026 laboratory study tested three products sold as retatrutide in Australia. All three matched the expected molecular weight, but the measured peptide content ranged from 51% to 190% of the labelled amount, a three-product sample that cannot show what the wider market holds (Piatkowski et al., Drug and Alcohol Review, 2026). A 2026 case report describes one woman in her mid-20s with five days of nausea and vomiting that resolved within a week after exposure to an unverified product reported to contain retatrutide, with probable causality on the Naranjo scale, and a single case cannot show how common this is (Buzzi et al., BMJ Case Reports, 2026).

These records describe specific products and specific people. They cannot show how common such harms are, and they are not trial data. Retatrutide's legal status in Australia sets out the TGA statements with their dates.

The Lancet 2022Cell Metabolism 2022ClinicalTrials.gov NCT04143802

Which clinical trial paper reports retatrutide's half-life?

The Phase 1b trial of 72 adults with type 2 diabetes reports retatrutide's half-life as approximately six days and its pharmacokinetics as dose proportional, in a small early-phase trial funded by the developer that describes that group only (Urva et al., The Lancet, 26 November 2022). The registry lists the trial as enrolling those 72 adults at four US centres from 18 December 2019 to 28 December 2020 (ClinicalTrials.gov NCT04143802). The first-in-human study in Cell Metabolism reports a separate pharmacokinetic profile in 45 healthy adults, from a small single-exposure study that describes those adults only (Coskun et al., 2022).

Pharmacokinetics means what the body does to a compound over time. The pharmacokinetics page sets out the half-life range, the time to peak concentration and the gaps in the record, such as the absence of a published human metabolism study among the sources checked.

The Lancet 2026 (TRIUMPH-2)NEJM 2023

Do these side-effect records apply to research-use retatrutide?

No. The trial figures on this page come from trial drug product given to enrolled participants who were screened and monitored by trial staff (Bellido et al., The Lancet, 2026; Jastreboff et al., NEJM, 2023), and the regulator and case-report records describe products from outside trials whose contents were unverified at the time of exposure, although the TGA later tested one of them in a laboratory (TGA safety alert, 14 September 2026). Research-use retatrutide is a laboratory compound. Research material is not a medicine, is not a substitute for one, and is not for human or animal use. No side-effect record here describes it, and these records cannot establish the effects of other products.

What exists for laboratory work is reference material with paperwork. This site's retatrutide reference material listing is freeze-dried laboratory stock. Available reports cover historical samples, and matching current certification is unverified. The retatrutide research guide covers the compound itself.

Comparison

Side effects listed in the retatrutide Phase 2 obesity trial (NCT04881760; 338 adults; 48 weeks; developer-funded; results first posted 13 September 2023). Retatrutide figures add the six retatrutide arms from the registry. The registry lists only events reported by 5% or more of people in any arm. One trial, so not a verdict on safety.

Comparison: Retatrutide side effects: what trials and regulators have recorded
EventRegistry count in this one trial (retatrutide arms pooled, 267 people, against placebo, 70 people)
Nausea83 of 267 retatrutide participants (31%) against 8 of 70 on placebo (11%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Decreased appetite56 of 267 retatrutide participants (21%) against 6 of 70 on placebo (9%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Diarrhoea37 of 267 retatrutide participants (14%) against 8 of 70 on placebo (11%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Vomiting33 of 267 retatrutide participants (12%) against 1 of 70 on placebo (1%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Constipation30 of 267 retatrutide participants (11%) against 2 of 70 on placebo (3%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Fatigue19 of 267 retatrutide participants (7%) against 3 of 70 on placebo (4%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Increased lipase (a pancreas enzyme)15 of 267 retatrutide participants (6%) against 2 of 70 on placebo (3%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Hypertension14 of 267 retatrutide participants (5%) against 2 of 70 on placebo (3%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Gastro-oesophageal reflux13 of 267 retatrutide participants (5%) against 1 of 70 on placebo (1%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Dizziness12 of 267 retatrutide participants (4%) against 2 of 70 on placebo (3%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Headache11 of 267 retatrutide participants (4%) against 0 of 70 on placebo (0%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only
Hypotension6 of 267 retatrutide participants (2%) against 0 of 70 on placebo (0%); ClinicalTrials.gov NCT04881760, Phase 2 obesity trial of 338 adults, 5% reporting threshold, one trial only

FAQ

What are the potential side effects of retatrutide?

In TRIUMPH-2, a developer-funded trial of 1,152 adults with type 2 diabetes, diarrhoea affected 27% to 34% of retatrutide participants against 13% on placebo, and dysaesthesia 4% to 7% against 1%, results for that trial population only (Bellido et al., The Lancet, 2026). Trial lists are not a full label, because the TGA reported on 14 September 2026 that retatrutide is not approved by it or a comparable international regulator.

Is retatrutide safe?

No trial or regulator gives a yes-or-no answer. The TGA reported no approval by it or a comparable international regulator, the longest obesity trial papers read here ran 80 weeks, and the sponsor funded every trial (TGA safety alert, 14 September 2026; Bellido et al., The Lancet, 2026).

What are the recorded risks of retatrutide?

The Phase 2 obesity paper of 338 adults recorded heart-rate increases, in a developer-funded trial that describes that population only (Jastreboff et al., NEJM, 2023), and TRIUMPH-2 recorded low blood pressure and altered skin sensation in 1,152 adults with type 2 diabetes, results for that trial population only (Bellido et al., The Lancet, 2026). The 338-adult Phase 2 obesity registry lists serious events in 4% of retatrutide participants and 4% on placebo, a trial too small to show rare events (ClinicalTrials.gov NCT04881760). The TGA found no retatrutide in one laboratory-tested product sold as retatrutide, a single-sample finding that cannot establish the frequency of mislabelling (TGA safety alert, 14 September 2026).

Has retatrutide been linked to liver injury?

Victoria's Chief Health Officer reported six cases of acute liver injury in people who had used products labelled retatrutide, and said a contaminant may be involved, in an alert about case reports that does not establish cause (Victorian health alert, 19 June 2026). The trial papers read for this page do not report liver injury as a main finding, and the full tables were not read.

Does retatrutide affect the kidneys?

In a post hoc analysis of the two Phase 2 trials (281 adults with type 2 diabetes and 338 with overweight or obesity), run after the trials rather than planned as their main question and by authors including developer employees, eGFR was unchanged in people with type 2 diabetes and higher in people with obesity, and albumin in urine fell (Heerspink et al., Kidney International Reports, 2025).

Can retatrutide cause hair loss?

No retatrutide hair-loss rate appears in the sources read for this page. The posted side-effect tables of the Phase 2 obesity trial of 338 adults (ClinicalTrials.gov NCT04881760) and the Phase 2 type 2 diabetes trial of 281 adults (ClinicalTrials.gov NCT04867785) list events reported by 5% or more of people in any arm and do not list it, which does not establish its actual frequency, and the question is set out on the study findings page.

What is retatrutide's half-life?

Approximately six days in the 72-adult Phase 1b trial in type 2 diabetes, where the pharmacokinetics were also dose proportional, in a small early-phase trial funded by the developer (Urva et al., The Lancet, 2022).

Citations

11 sources
  1. Bellido V et al. The Lancet. 2026;408(10563):1455-1472.
    doi:10.1016/S0140-6736(26)01861-1

  2. Jastreboff AM et al. New England Journal of Medicine. 2023;389(6):514-526.
    doi:10.1056/NEJMoa2301972

  3. Jastreboff AM et al. New England Journal of Medicine. 2026, online 29 September (TRIUMPH-1).
    doi:10.1056/NEJMoa2604169

  4. Bajaj HS et al. The Lancet. 2026;407(10546):2402-2413.
    doi:10.1016/S0140-6736(26)00967-0

  5. Rosenstock J et al. The Lancet. 2023;402(10401):529-544.
    doi:10.1016/S0140-6736(23)01053-X

  6. Urva S et al. The Lancet. 2022;400(10366):1869-1881.
    doi:10.1016/S0140-6736(22)02033-5

  7. Coskun T et al. Cell Metabolism. 2022;34(9):1234-1247.e9.
    doi:10.1016/j.cmet.2022.07.013

  8. Heerspink HJL et al. Kidney International Reports. 2025;10(6):1980-1992.
    doi:10.1016/j.ekir.2025.03.049

  9. Laroche ML et al. European Journal of Clinical Pharmacology. 2026;82(6).
    doi:10.1007/s00228-026-04079-7

  10. Piatkowski T et al. Drug and Alcohol Review. 2026;45(6):e70231.
    doi:10.1111/dar.70231

  11. Buzzi RM et al. BMJ Case Reports. 2026;19(10).
    doi:10.1136/bcr-2026-276106

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