Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea
- Design
- Randomized trial · 691 participants · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Different populationINDIRECT: all participants had moderate-to-severe OSA and a BMI of at least 27 (mean body weight 119.6 and 115.9 kg); TRIUMPH-2-OSA enrolled only people with type 2 diabetes.
- Could weight loss explain it?
- LikelyLikely: body weight fell by -12.5 to -22.2% (TRIUMPH-1-OSA) and -12.1 to -18.5% (TRIUMPH-2-OSA) with retatrutide, and sleep apnoea is known to improve with weight loss. The abstract reports no analysis separating the AHI effect from weight loss.
- Study tier
- Study tier 2MODERATE: two phase 3, double-blind, placebo-controlled randomized trials (243 and 448 participants) with an intermediate outcome (AHI) at 80 weeks; funded by Eli Lilly.
- Assessment
- Version 3 · Two independent AI reviews agreed · Nov 7, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
Two placebo-controlled trials randomized 243 adults without diabetes and 448 with type 2 diabetes, all with moderate-to-severe obstructive sleep apnea and a BMI of at least 27, to weekly retatrutide or placebo, with results at 80 weeks. Retatrutide reduced breathing interruptions during sleep more than placebo at every dose (for 9 mg, -24.4 and -14.4 events per hour versus placebo in the two trials), while body weight fell by up to -22.2%. Much of the benefit may reflect that weight loss; side effects were mostly gastrointestinal, and the trials were funded by Eli Lilly.
01Findings
What the study reported
- Drugs
- Retatrutide
- Dose
- 4, 9, or 12 mg once weekly
- Route
- subcutaneous
- Comparator
- placebo
- Primary outcome
- change in the apnea-hypopnea index (AHI) at 80 weeks with 9 mg and 12 mg
- Effect
- AHI difference vs. placebo at 80 weeks (hybrid-treatment estimand): TRIUMPH-1-OSA -13.0 (4 mg), -24.4 (9 mg), -21.9 (12 mg); TRIUMPH-2-OSA -8.9, -14.4, -15.1 events per hour; ITT differences similar; body weight -12.5 to -22.2% and -12.1 to -18.5% vs. -4.8% and -5.6% with placebo
- 95% confidence interval
- TRIUMPH-1-OSA: 9 mg 95% CI, -34.1 to -14.7; 12 mg 95% CI, -32.2 to -11.5. TRIUMPH-2-OSA: 9 mg 95% CI, -21.6 to -7.2; 12 mg 95% CI, -22.5 to -7.7 (hybrid-treatment estimand)
- Follow-up
- 80 weeks
- Adverse events
- The most common adverse events were gastrointestinal.
- Limitations
- Each OSA trial was nested in a larger basket trial of an investigational drug; all participants had overweight or obesity and lost substantial weight, so the AHI effect cannot be separated from weight loss; the primary analysis used a hybrid estimand, with ITT results alongside.
Who was studied
- Bmi min
- 27
- Obesity status
- overweight or obesity required (body-mass index of at least 27)
- Diabetes status
- mixed: excluded in TRIUMPH-1-OSA, required in TRIUMPH-2-OSA
- Baseline condition
- moderate-to-severe obstructive sleep apnea
- Sample size
- 691
- Inclusion exclusion
- adults with moderate-to-severe OSA and BMI at least 27, without (TRIUMPH-1-OSA) or with (TRIUMPH-2-OSA) type 2 diabetes
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 691
- Randomization
- yes
- Blinding
- double-blind
- Comparator
- placebo
- Follow up duration
- 80 weeks
- Outcome type
- intermediate
- Replication
- not assessed
- Consistency with other evidence
- not assessed
- Population applicability
- INDIRECT
- Statistical precision
- CI reported: TRIUMPH-1-OSA: 9 mg 95% CI, -34.1 to -14.7; 12 mg 95% CI, -32.2 to -11.5. TRIUMPH-2-OSA: 9 mg 95% CI, -21.6 to -7.2; 12 mg 95% CI, -22.5 to -7.7 (hybrid-treatment estimand)
- Risk of bias
- not assessed
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- Eli Lilly
- Industry funded
- Yes
- Manufacturer
- Eli Lilly
- Sponsor role
- not reported in abstract
- Author conflicts
- not reported in abstract
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[BACKGROUND] Retatrutide, an investigational triple agonist of glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and glucagon receptors, may be useful for treating obstructive sleep apnea (OSA). [METHODS] In two phase 3, double-blind, randomized, placebo-controlled trials nested within larger basket trials of once-weekly subcutaneous retatrutide, we assigned adults with moderate-to-severe OSA and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 27, without (TRIUMPH-1-OSA) or with (TRIUMPH-2-OSA) type 2 diabetes, to receive retatrutide (4, 9, or 12 mg) or placebo. The primary end point was the change in the apnea-hypopnea index (AHI, the average number of apneas and hypopneas per hour of sleep) at 80 weeks with 9 mg and 12 mg of retatrutide. For OSA-related end points, a hybrid-treatment estimand was applied, with a hypothetical strategy used for participants who had intercurrent events suggesting treatment failure and a treatment-policy strategy used elsewhere. We also report intention-to-treat (ITT) results. [RESULTS] A total of 243 participants underwent randomization in TRIUMPH-1-OSA and 448 in TRIUMPH-2-OSA. The baseline mean AHI was 58.6 and 55.9 events per hour, respectively, and the mean body weight was 119.6 and 115.9 kg. At 80 weeks, the mean changes in the AHI (hybrid-treatment estimand) with retatrutide in TRIUMPH-1-OSA were -22.9 (4 mg), -34.3 (9 mg), and -31.7 (12 mg) events per hour, versus -9.9 with placebo (difference vs. placebo, -13.0 [95% confidence interval {CI}, -23.0 to -3.0], -24.4 [95% CI, -34.1 to -14.7], and -21.9 [95% CI, -32.2 to -11.5], respectively). The changes with retatrutide in TRIUMPH-2-OSA were -19.2 (4 mg), -24.7 (9 mg), and -25.4 (12 mg) events per hour, versus -10.3 with placebo (difference vs. placebo, -8.9 [95% CI, -15.9 to -2.0], -14.4 [95% CI, -21.6 to -7.2], and -15.1 [95% CI, -22.5 to -7.7]). For the ITT estimand, the corresponding differences from placebo were -13.2 (95% CI, -22.6 to -3.9), -24.7 (95% CI, -34.1 to -15.3), and -22.5 (95% CI, -31.9 to -13.1) in TRIUMPH-1-OSA and -8.8 (95% CI, -15.8 to -1.7), -13.9 (95% CI, -21.3 to -6.6), and -15.0 (95% CI, -22.5 to -7.4) in TRIUMPH-2-OSA. The mean percent change in body weight with retatrutide (key secondary end point) was -12.5 to -22.2% in TRIUMPH-1-OSA and -12.1 to -18.5% in TRIUMPH-2-OSA, versus -4.8% and -5.6% with placebo (treatment-regimen estimand). The most common adverse events were gastrointestinal. [CONCLUSIONS] In adults with OSA and obesity or overweight with or without type 2 diabetes, retatrutide resulted in significantly greater decreases in the AHI than placebo. (Funded by Eli Lilly; TRIUMPH-1 and -2 ClinicalTrials.gov numbers, NCT05929066 and NCT05929079.).
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Oct 25, 2026 | 42904878 first ingestion |
| pubmed | Oct 25, 2026 | 42904878 duplicate matched on doi |
| pubmed | Nov 1, 2026 | 42904878 duplicate matched on doi |
| pubmed | Nov 1, 2026 | 42904878 duplicate matched on doi |
| owner-review | Nov 6, 2026 | reviewed_by set to Carrie Schluter (2026-11-05) on the owner's own confirmation. The assessment is unchanged and still the auto-classifier's, so its extracted values stay withheld under the 2026-10-18 decision. |
| reextract | Nov 6, 2026 | manufacturer: 'Eli Lilly, Lilly' -> 'Eli Lilly'; dose: '12 mg' -> '4 mg, 9 mg, 12 mg'. Q-043: manufacturer and drug_details.dose re-extracted by auto-classifier-v1.2. manufacturer no longer reads companies named only in the authors' conflicts statement (IN-062) and refuses a multi-company roster; dose is tied to the GLP-1 agent by name, never reads a concentration, and records a multi-dose design whole. Every other value is carried forward unchanged. Owner decision IN-064 option 1, 2026-11-06. |