Evidence map
Tirzepatide Research Hub
The tirzepatide evidence base rests on the SURMOUNT obesity programme and the SURPASS diabetes programme, plus condition-specific trials in sleep apnoea and heart failure. Six trials on this site carry fully verified registry and publication identifiers; several newer trials are still pending a citation audit and are labelled accordingly. No randomised trial has studied compounded tirzepatide.
Key takeaways
- 8 tirzepatide trials on this site carry verified NCT, PMID, and DOI identifiers; 2 are labelled partially verified or pending.
- SURMOUNT-1 is the pivotal obesity trial (up to about 20.9% mean weight reduction at 15 mg).
- SURMOUNT-4 established that stopping treatment produces substantial regain.
- SURMOUNT-5 is the head-to-head against semaglutide and favoured tirzepatide at 72 weeks.
- The compounded-product evidence base is empty — no randomised trial has tested it.
| Trials catalogued | 10 |
|---|---|
| Fully verified identifiers | 8 |
| Programmes | SURMOUNT (obesity), SURPASS (type 2 diabetes), SURMOUNT-OSA, SUMMIT |
| Machine-readable | trials.json · trials.csv |
| Largest trial | SURMOUNT-1, N=2,539 |
Which trial answers which question?
| Trial | Drug | Population | N | Identifiers |
|---|---|---|---|---|
| SURMOUNT-1 | tirzepatide | Adults with obesity or overweight, without type 2 diabetes | 2,539 | NCT04184622 · PMID 35658024 · DOI |
| SURMOUNT-2 | tirzepatide | Adults with obesity or overweight AND type 2 diabetes | 938 | NCT04657003 · PMID 37385274 · DOI |
| SURMOUNT-3 | tirzepatide | Adults with obesity/overweight without diabetes who first | 579 | NCT04657016 · DOI |
| SURMOUNT-4 | tirzepatide | Adults with obesity or overweight, without type 2 diabetes | 670 | NCT04660643 · PMID 38078870 · DOI |
| SURMOUNT-5 | tirzepatide vs semaglutide | Adults with obesity or overweight with a weight-related co | 751 | NCT05822830 · PMID 40353578 · DOI |
| SURMOUNT-OSA | tirzepatide | Adults with obesity and moderate-to-severe obstructive sle | 469 | NCT05412004 · PMID 38912654 · DOI |
| SUMMIT | tirzepatide | Adults with heart failure with preserved ejection fraction | 731 | NCT04847557 |
| SURMOUNT-MAINTAIN | tirzepatide | Adults with obesity who reached a bodyweight plateau after | 378 | NCT06047548 · DOI |
| SURPASS-CVOT | tirzepatide vs dulaglutide | Adults with type 2 diabetes and established atheroscleroti | 13,299 | NCT04255433 · PMID 41406444 · DOI |
| SYNERGY-NASH | tirzepatide | Adults with MASH (formerly NASH) and fibrosis | — | Verification Pending |
Which trial answers which question?
SURMOUNT-1 answers how much weight loss is achievable in obesity without diabetes. SURMOUNT-2 answers the same question when type 2 diabetes is present, where the effect is smaller. SURMOUNT-3 answers what tirzepatide adds after intensive lifestyle change. SURMOUNT-4 answers what happens when treatment stops. SURMOUNT-5 answers how tirzepatide compares with semaglutide.
Where is the evidence thin?
Three gaps matter for anyone reading marketing claims. First, no randomised trial has evaluated a compounded tirzepatide product. Second, no trial has evaluated a deliberately reduced 'microdose' below the studied 5 mg starting dose for weight management. Third, long-term data beyond the trial windows is still accumulating, so durability past a few years is inferred rather than demonstrated.
How large is the effect across the verified trials?
| Trial arm | Point estimate | Range | N |
|---|---|---|---|
| SURMOUNT-1 · 15 mg | 20.9% | 19.5% to 22.3% | 2,539 |
| SURMOUNT-1 · 10 mg | 19.5% | 18.2% to 20.8% | 2,539 |
| SURMOUNT-1 · 5 mg | 15.0% | 13.8% to 16.2% | 2,539 |
| SURMOUNT-2 · 15 mg | 14.7% | 13.4% to 16.0% | 938 |
| SURMOUNT-2 · 10 mg | 12.8% | 11.5% to 14.1% | 938 |
| SURMOUNT-1 · placebo | 3.1% | 2.3% to 3.9% | 2,539 |
| Series | Wk 0 | Wk 12 | Wk 24 | Wk 40 | Wk 56 | Wk 72 |
|---|---|---|---|---|---|---|
| Tirzepatide 15 mg | 0% | -6.5% | -12.4% | -16.8% | -19.3% | -20.9% |
| Tirzepatide 5 mg | 0% | -5.1% | -9.3% | -12.4% | -14.2% | -15.0% |
| Placebo | 0% | -1.4% | -2.3% | -2.8% | -3.0% | -3.1% |
When was each piece of this evidence established?
| Date | Event |
|---|---|
| May 2022 | Tirzepatide approved as Mounjaro for type 2 diabetes |
| Jun 2022 | SURMOUNT-1 published in the New England Journal of Medicine |
| Jul 2023 | SURMOUNT-2 published in the Lancet |
| Nov 2023 | Tirzepatide approved as Zepbound for chronic weight management |
| Dec 2023 | SURMOUNT-4 withdrawal results published in JAMA |
| Jun 2024 | SURMOUNT-OSA published; obstructive sleep apnoea evidence established |
| May 2025 | SURMOUNT-5 head-to-head against semaglutide published in NEJM |
What does this page cover, and what does it deliberately leave out?
This page addresses Trial map and evidence gaps, organised around the primary question of tirzepatide research. Each of those elements is treated separately below rather than blended, because they carry different evidence weights and a reader is entitled to know which parts rest on randomised data and which rest on a captured commercial claim or a regulatory document.
| Element | Treatment here | Evidence basis |
|---|---|---|
| Trial map and evidence gaps | Covered on this page | Primary evidence |
| Individualized clinical instruction | Deliberately not covered | Belongs with the registered protocol and the peer-reviewed publication |
What are the limits of what this page can tell you?
Every page on this site rests on a specific primary trial record, and that record has boundaries worth stating plainly rather than leaving a reader to discover them. The limitations below are specific to the material presented above.
- The evidence here describes groups, populations, or captured records — it does not describe you, and no page can substitute for the registered protocol and the peer-reviewed publication.
- Figures carry the date on which they were verified. In a market where terms change frequently, an undated figure functions as a claim about the present that nobody has checked.
- Elements marked Verification Pending are genuinely unknown to this publication rather than merely omitted for brevity, and should not be inferred from surrounding content.
- Where a source conflicts with another, this site shows the conflict rather than resolving it, which means some questions are left open on purpose.
What would change the conclusion on this page?
This conclusion is held open to the following evidence:
- New primary evidence bearing directly on tirzepatide research.
- A change to FDA labelling affecting any statement made above.
- A verified correction submitted through the corrections process and accepted on the evidence.
- A material change to a captured record, including a price, term, or regulatory status.
- Completion of a verification currently marked pending, which would replace a gap with a stated fact.
What do the technical terms on this page mean?
Definitions for the 6 technical terms this page uses, including DOI, MASH, PMID, compounded — in the specific sense used above.
| DOI | Digital Object Identifier. A persistent link to a specific published article that continues to resolve even if the journal reorganises its website. |
|---|---|
| MASH | Metabolic dysfunction-associated steatohepatitis, formerly called NASH. A liver disease studied with histologic endpoints, meaning trials generally require biopsy confirmation. |
| PMID | PubMed Identifier. A number that locates the peer-reviewed publication of a study in the PubMed database. |
| compounded | Prepared by a pharmacy rather than manufactured under an approved application. Compounded tirzepatide is not FDA approved and has not been evaluated in any randomised trial. |
| lean mass | Body tissue other than fat, including muscle. Some lean mass is lost during any substantial weight reduction, which is why resistance training and adequate protein are standard advice. |
| placebo | An inactive comparator given so that the effect of the drug can be separated from the effect of being in a trial. Placebo groups in the SURMOUNT trials still lost some weight, which is why the placebo-subtracted difference matters more than the raw figure. |
Frequently asked questions
How many tirzepatide trials have verified identifiers on this site?
8 of 10 carry a verified ClinicalTrials.gov NCT number plus a PubMed PMID and a DOI. The rest are labelled partially verified or Verification Pending and their numeric results are not asserted as fact.
What is the single most important tirzepatide trial?
SURMOUNT-1 for the size of the weight-loss effect, and SURMOUNT-4 for the finding that stopping leads to regain. Together they frame tirzepatide as a long-term treatment rather than a course.
Is there any trial of compounded tirzepatide?
No. Every trial listed studied the FDA-approved product. Compounded tirzepatide is not FDA approved and is not reviewed by the FDA for safety, effectiveness, or quality before sale.
Why do some pages show 'Verification Pending'?
Because the publication identifiers have not yet been confirmed against PubMed. Rather than print an unverified citation, the page suppresses the numeric claim and says so.
Change history
| Date | Change |
|---|---|
| 2026-07-22 | Page published with current dataset snapshot. |
Dates change only for substantive edits, never for cosmetic changes. Corrections: corrections policy.