Primary outcome
What SYNERGY-NASH measured first
| 5 mg Tirzepatiden=39 | 10 mg Tirzepatiden=41 | 15 mg Tirzepatiden=40 | Placebon=35 |
|---|---|---|---|
| 51.84 | 63.13 | 73.92 | 12.62 |
Phase 2 · Tirzepatide
SYNERGY-NASH trial results
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology (Percentage of participants), Week 52. 5 mg Tirzepatide: 51.84; 10 mg Tirzepatide: 63.13; 15 mg Tirzepatide: 73.92; Placebo: 12.62.
- Participants
- 190
- Status
- completed
- Completed
- 2024-01-10
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT04166773), updated at source Jan 24, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in SYNERGY-NASH
Percent of participants affected, Baseline Up to Week 56. The most common events the registry lists.
| Event | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide | Placebo |
|---|---|---|---|---|
| Any serious event | 10.6% | 8.5% | 0% | 6.3% |
| Nausea | 36.2% | 34% | 43.8% | 12.5% |
| Diarrhoea | 31.9% | 36.2% | 27.1% | 22.9% |
| Constipation | 23.4% | 19.1% | 14.6% | 6.3% |
| Decreased appetite | 19.1% | 21.3% | 22.9% | 2.1% |
| Covid-19 | 10.6% | 12.8% | 18.8% | 8.3% |
| Dyspepsia | 4.3% | 17% | 4.2% | 4.2% |
| Vomiting | 6.4% | 6.4% | 14.6% | 2.1% |
| Abdominal pain | 12.8% | 6.4% | 8.3% | 6.3% |
| Abdominal pain upper | 12.8% | 4.3% | 0% | 4.2% |
| Dizziness | 4.3% | 12.8% | 8.3% | 4.2% |
| Headache | 6.4% | 12.8% | 6.3% | 10.4% |
| Abdominal distension | 6.4% | 6.4% | 12.5% | 8.3% |
| Weight decreased | 10.6% | 6.4% | 8.3% | 0% |
| Arthralgia | 10.6% | 4.3% | 4.2% | 2.1% |
| Fatigue | 8.5% | 8.5% | 10.4% | 6.3% |
| Abdominal discomfort | 2.1% | 8.5% | 0% | 0% |
| Asthenia | 6.4% | 8.5% | 0% | 4.2% |
| Alopecia | 8.5% | 4.3% | 6.3% | 0% |
| Eructation | 2.1% | 4.3% | 8.3% | 0% |
| Gastrooesophageal reflux disease | 4.3% | 6.4% | 8.3% | 0% |
| Urinary tract infection | 4.3% | 6.4% | 4.2% | 8.3% |
| Flatulence | 4.3% | 6.4% | 6.3% | 2.1% |
| Upper respiratory tract infection | 4.3% | 6.4% | 2.1% | 0% |
| Taste disorder | 0% | 6.4% | 2.1% | 0% |
| Hypertension | 0% | 6.4% | 0% | 0% |
Secondary outcomes
What else it measured
| 5 mg Tirzepatiden=39 | 10 mg Tirzepatiden=41 | 15 mg Tirzepatiden=40 | Placebon=35 |
|---|---|---|---|
| 59.21 | 53.35 | 54.3 | 32.51 |
| 5 mg Tirzepatiden=39 | 10 mg Tirzepatiden=41 | 15 mg Tirzepatiden=40 | Placebon=35 |
|---|---|---|---|
| 12.04 | 9.81 | 5.53 | 13.03 |
| 5 mg Tirzepatiden=39 | 10 mg Tirzepatiden=41 | 15 mg Tirzepatiden=40 | Placebon=35 |
|---|---|---|---|
| 81.02 | 86.55 | 88.77 | 38.09 |
| 5 mg Tirzepatiden=28 | 10 mg Tirzepatiden=33 | 15 mg Tirzepatiden=32 | Placebon=27 |
|---|---|---|---|
| -10.12(1.165) | -10.15(1.071) | -11.34(1.107) | -1.31(1.142) |
| 5 mg Tirzepatiden=40 | 10 mg Tirzepatiden=42 | 15 mg Tirzepatiden=42 | Placebon=37 |
|---|---|---|---|
| -11.46(1.404) | -14.22(1.380) | -17.88(1.376) | -1.04(1.392) |
The trial
How SYNERGY-NASH was run
The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).
- 5 mg Tirzepatide: 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
- 10 mg Tirzepatide: 10 mg tirzepatide administered SC once a week.
- 15 mg Tirzepatide: 15 mg tirzepatide administered SC once a week.
- Placebo: Placebo administered SC once a week.
Who could join the trial
* Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months * Participants with or without type 2 diabetes mellitus (T2DM) * If with T2DM, hemoglobin A1c (HbA1c) ≤9.5% * Participants must be willing to undergo baseline and endpoint liver biopsies * Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy * Participants must not have known or suspected alcohol abuse (\>14 units/week for women and \>21 units/week for men) or active substance abuse * Participants must not have evidence of cirrhosis or other forms of liver disease * Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months * Participants must not have active cancer within the last 5 years * Participants must not have uncontrolled high blood pressure * Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) \<30 milliters/minute/1.73m²; for participants on metformin, eGFR \<45 mL/min/1.73m² * Participants must not have a diagnosis of type 1 diabetes * Participants must not have a history of pancreatitis (acute or chronic) * Participants must not have calcitonin ≥35 nanograms per liter * Participant must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative) * Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Published papers
Papers from SYNERGY-NASH
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.