Trial programme
The SURPASS Tirzepatide Trial Programme
SURPASS is the type 2 diabetes trial programme for tirzepatide, supporting the Mounjaro indication. Its trials tested glycaemic control and weight against placebo and against active comparators including insulin and other incretin therapies. The cardiovascular outcomes trial, SURPASS-CVOT, is tracked separately because outcome evidence is a different evidentiary category from glycaemic efficacy.
Key takeaways
- SURPASS trials support the type 2 diabetes indication marketed as Mounjaro.
- Several used active comparators rather than placebo, a more demanding design.
- Glycaemic and weight endpoints are efficacy surrogates, not outcome evidence.
- SURPASS-CVOT covers cardiovascular outcomes and is tracked as a separate record.
- Individual SURPASS trial identifiers are still being verified on this site.
| Indication supported | Type 2 diabetes (marketed as Mounjaro) |
|---|---|
| Endpoint type | HbA1c and body weight (efficacy surrogates) |
| Comparators | Placebo and active comparators including insulin and incretin therapies |
| Outcome trial | SURPASS-CVOT (tracked separately) |
| Verification status | Individual trial citations pending |
What distinguishes SURPASS from SURMOUNT?
Population and primary endpoint. SURPASS enrolled adults with type 2 diabetes and measured glycaemic control first, with weight as a secondary benefit. SURMOUNT enrolled adults with obesity — largely without diabetes — and measured weight first. The same molecule, studied for two different regulatory indications, marketed under two different brand names.
Why do active comparators matter?
A placebo-controlled trial answers whether a drug works. An active-comparator trial answers whether it works better than what patients already receive — a far more useful question for prescribing, and a harder standard to meet. Several SURPASS trials used this design, which strengthens the diabetes evidence relative to a placebo-only programme.
What the evidence shows
- Tirzepatide improved glycaemic control and weight in type 2 diabetes across the programme.
- Some trials used active comparators rather than placebo alone.
What the evidence does not show
- That glycaemic improvement by itself demonstrates cardiovascular benefit.
- That SURPASS results apply to compounded tirzepatide.
- Numeric per-trial results on this page — those await citation verification.
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 Diabetes trial map, comparators and glycemic/weight outcomes, organised around the primary question of SURPASS tirzepatide trials. 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 |
|---|---|---|
| Diabetes trial map | Covered on this page | Primary evidence |
| Comparators | Covered on this page | Primary evidence |
| Glycemic/weight outcomes | 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 page would be revised, with the change recorded in its history, if any of the following occurred:
- New primary evidence bearing directly on SURPASS tirzepatide trials.
- 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, PMID, compounded, endpoint — 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. |
|---|---|
| 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. |
| endpoint | The outcome a trial is designed to measure. A primary endpoint is specified before the trial begins; secondary and exploratory endpoints carry progressively weaker inferential weight. |
| incretin | A gut hormone released in response to food that amplifies insulin secretion. GIP and GLP-1 are the two principal human incretins, and the drug class that mimics them is named after them. |
| 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
What is SURPASS?
The phase 3 trial programme supporting tirzepatide's type 2 diabetes indication, marketed as Mounjaro.
How is it different from SURMOUNT?
SURPASS studied type 2 diabetes with glycaemic endpoints; SURMOUNT studied obesity with weight endpoints.
Why are no numbers on this page?
Individual SURPASS citations are pending verification, so numeric results are withheld.
Does better HbA1c mean fewer heart attacks?
Not automatically. That is what the separate cardiovascular outcomes trial is designed to test.
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.