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The Estimand Lesson

Survodutide

Also known as BI 456906

Summary coverage

At a glance

What it is
Glucagon/GLP-1 dual agonist. Not approved anywhere; the numbers depend on the question.
Evidence
Clinical trialsHow the tiers workSYNCHRONIZE-1 (NEJM, 7 June 2026, n=725, NCT06066515) reported week-76 weight change on the treatment-regimen estimand as −12.2% on 3.6 mg and −13.0% on 6.0 mg against −5.4% on placebo, with 72.6%, 71.9% and 46.3% losing at least 5%. Why this tier
Half-life
Not established in available literature
Routes
Subcutaneous
Category
Metabolic
FDA
Investigational
As of 3 August 2026. What that means
WADA
We do not state a status

Putting Survodutide on a schedule, with the vial it comes from and a log of each dose, happens in the app: Claritide for iPhone.

Evidence

Why this tier

SYNCHRONIZE-1 (NEJM, 7 June 2026, n=725, NCT06066515) reported week-76 weight change on the treatment-regimen estimand as −12.2% on 3.6 mg and −13.0% on 6.0 mg against −5.4% on placebo, with 72.6%, 71.9% and 46.3% losing at least 5%. The press release and conference coverage headline the same trial as up to 16.6% weight loss against 3.2% placebo, with 85.1% reaching at least 5%. Both sets of numbers are true and they answer different questions. A separate Phase 3 in metabolic dysfunction-associated steatotic liver disease was published in Nature Medicine on the same day.

Overview

What it is

Survodutide is a glucagon receptor and GLP-1 receptor dual agonist from Boehringer Ingelheim and Zealand Pharma, given once weekly by subcutaneous injection. It is not approved anywhere and is available only through gray-market channels. It is also the cleanest teaching case we have for how the same trial produces two different headline numbers depending on which question is asked.

Mechanism

How it works

Survodutide activates two receptors. The GLP-1 arm does the familiar work: appetite suppression through the brain, slowed gastric emptying, glucose-dependent insulin release. The glucagon arm is the addition: glucagon receptor agonism increases energy expenditure and drives hepatic fat oxidation, which is why the dual agonists are being trialled in liver disease as well as obesity. Glucagon on its own would raise blood sugar; simultaneous GLP-1 activation counterbalances that.

Dosing

Commonly researched ranges

These are figures reported in published literature and practitioner protocols: a commonly researched range, not a recommendation. Claritide does not tell you what to take.
  • Phase 3 maintenance doses (SYNCHRONIZE-1)3.6–6 mg

    Once weekly, after titration

    Two doses, not a band: NCT06066515 studied 3.6 mg and 6.0 mg over 76 weeks and nothing in between. The titration up to them is described as extended and flexible, and its steps are not published, so no intermediate figure exists to show. Investigational; there is no approved regimen.

Cycle guidance
Not established in available literature
Goals
Fat loss
Legal standing

Where this sits with the FDA

Dated, sourced, and separate from whether it works. Removal from a warning list is not permission to compound.
Investigationalas of 3 August 2026 · US

Survodutide is in Phase 3 development and is not approved anywhere. It appears in gray-market channels, which means anything obtained outside a trial has no manufacturer, no label and no chain of custody.

Primary source
Sport

WADA status

The 2026 Prohibited List entered force on 1 January 2026.
We do not state a status

Not named on the 2026 Prohibited List. Semaglutide and tirzepatide sit on the Monitoring Program rather than the List; we could not determine survodutide’s classification and do not state one.

We looked and could not resolve it. This is not the same as "not prohibited". Treat it as unresolved and check with your federation before competing.

Reconstitution

Mixing recipes our sources document

Concentration (mg/mL) = vial mg ÷ diluent mL. On a U-100 barrel, 1 unit = 0.01 mL.

Not established in available literature. Use the calculator with the figures printed on your own vial.
Open the calculator

Expectations

Week by week

What our material describes people reporting. Individual responses vary widely.

Not established in available literature.

Tolerability

Side effects

Grouped by how often our sources report them. Percentages appear only where a published trial figure exists.

Common

  • Gastrointestinal adverse events89.7% in trialsIn SYNCHRONIZE-1: 80.9% on 3.6 mg and 89.7% on 6.0 mg, against 47.9% on placebo, typically mild to moderate. No deaths.
Safety

Contraindications and interactions

Do not use if

Not established in available literature.

Interactions

Not established in available literature.

Absence from this list does NOT mean safety. It means lack of research.

Handling

Storage and cost

Storage
Our sources publish no reconstitution or storage protocol for survodutide.
Cost
Not established in available literature
Deep dive

Survodutide in full

Limited coverage

Survodutide is a glucagon receptor and GLP-1 receptor dual agonist from Boehringer Ingelheim and Zealand Pharma. Once weekly, subcutaneous, titrated to 3.6 mg or 6.0 mg. Not approved anywhere.

Why it is here

Because of what its Phase 3 shows about reading trial results.

SYNCHRONIZE-1, published in the New England Journal of Medicine on 7 June 2026, 725 participants, NCT06066515. At week 76, on the treatment-regimen estimand, weight change was −12.2% on 3.6 mg and −13.0% on 6.0 mg, against −5.4% on placebo. At least 5% loss was achieved by 72.6%, 71.9% and 46.3% respectively.

The press release and the conference coverage of the same trial headline up to 16.6% weight loss at 76 weeks against 3.2% placebo, with 85.1% reaching at least 5%.

Neither set is wrong. They are different estimands, different formal questions asked of the same data. Roughly: "what happened to everyone randomised, including people who stopped or added another drug" versus "what happens if you take it as directed and keep taking it". The first is what you would expect in the world. The second is what the drug can do under ideal conditions.

Almost every weight-loss figure you will see quoted somewhere is one of these two, and almost nobody says which.

Tolerability

Gastrointestinal adverse events ran 80.9% on 3.6 mg and 89.7% on 6.0 mg, against 47.9% on placebo, typically mild to moderate, with no deaths. That is a high GI burden even for this class.

A separate Phase 3 in metabolic dysfunction-associated steatotic liver disease was published in Nature Medicine on the same day, reflecting where the glucagon arm is expected to matter most.

References

Sources

  1. 1
    NEJM, 7 June 2026 · SYNCHRONIZE-1, survodutide in obesity, n=725
  2. 2
    ClinicalTrials.gov NCT06066515 · SYNCHRONIZE-1, Boehringer Ingelheim (completed; no results posted to the registry; read 27 September 2026)
  3. 3
    Nature Medicine, 7 June 2026 · survodutide Phase 3 in MASLD
  4. 4
    Boehringer Ingelheim · SYNCHRONIZE-1 results announcement
  5. 5
    SYNCHRONIZE-1/-2 design paper · the 3.6 mg and 6.0 mg maintenance doses, with titration described but its steps unpublished (dose review, 2026-08-17)

Every record in this library is free to read, and it stays free. Your own schedule, vials and log live in the app: Claritide for iPhone.