What Is Amycretin?

1. The Short Answer

Amycretin is the older development name for Novo Nordisk’s zenagamtide, an investigational unimolecular GLP-1 and amylin receptor agonist. Novo’s 2025 annual report describes zenagamtide, formerly known as amycretin, as a long-acting GLP-1 and amylin receptor agonist in phase 3 development for obesity and diabetes.

The unimolecular design is a key distinction. CagriSema combines two separate active components, cagrilintide and semaglutide. Amycretin (zenagamtide) is designed as a single molecule that acts at both GLP-1 and amylin receptors.

As of May 6, 2026, it is not an FDA-approved medicine. Novo’s own sources describe phase 3 development, not an approved U.S. label. If a website sells “amycretin” as a current product, it is not an approved zenagamtide formulation.

For nearby context, see What Is CagriSema? and What Is a GLP-1?.

2. Amycretin, Zenagamtide, and NNC0487-0111

There are multiple names associated with this drug. “Amycretin” is the older public development name. “Zenagamtide” is the newer name used in Novo’s 2025 annual report. “NNC0487-0111” is the development code that appears in ClinicalTrials.gov records.

Both names matter. Amycretin links older records to newer Novo materials, while zenagamtide reflects the updated terminology.

3. Is Amycretin FDA-Approved?

No. Amycretin, or zenagamtide, is not FDA-approved as of May 6, 2026. Novo states that phase 3 weight-management development is underway and that type 2 diabetes phase 3 development is planned, but these statements describe research progress rather than a U.S. product label.

An approved label defines the formal indication, dose, route, warnings, limitations, manufacturer labeling, and patient instructions. Amycretin does not currently have a public U.S. label.

The FDA has warned about non-FDA-approved GLP-1 drugs, including products marketed as alternatives to approved medications. This warning is relevant to amycretin, as an investigational research code or a trial result is not equivalent to an approved, commercially available product.

4. How Does Amycretin Work?

Amycretin is designed to act at GLP-1 and amylin receptors. Novo describes it as a unimolecular, long-acting GLP-1 and amylin receptor agonist. The Lancet oral amycretin paper describes a single-molecule GLP-1 receptor and amylin receptor agonist studied in adults with overweight or obesity.

Essentially, it combines two appetite-related mechanisms into one molecule.

The amylin activity is why amycretin gets compared with CagriSema, cagrilintide, and Symlin. The GLP-1 activity is why it gets pulled into Ozempic, Wegovy, and semaglutide discussions. Both comparisons are relevant, but neither fully captures the unimolecular design.

For background on older amylin medications, see What Is Symlin?. Symlin is pramlintide, an amylin analog, not a GLP-1 medicine. Amycretin sits in a newer mixed-receptor category.

5. Oral Amycretin Results

The first-in-human oral amycretin study was published in The Lancet in 2025. The ScienceDirect record describes a phase 1, randomized, double-blind, placebo-controlled study that enrolled 144 adults with overweight or obesity between May 11, 2022 and January 9, 2024.

The oral study tested single ascending doses and multiple ascending doses. In the longer phase, participants received once-daily oral amycretin in fixed titration regimens for up to 12 weeks. ClinicalTrials.gov lists the same study under NCT05369390 and describes NNC0487-0111 as similar to two hormones made in the human body: amylin and GLP-1.

The safety data is from early-stage trials. ScienceDirect notes that all treatment-emergent adverse events were mild or moderate, and the most common events were gastrointestinal. No deaths were reported in that record.

Regarding weight loss, the subcutaneous Lancet paper summarizes earlier oral data as showing a weight reduction of up to 13.1% after 12 weeks in people with overweight or obesity.

6. Subcutaneous Amycretin Results in Obesity

Novo announced phase 1b/2a subcutaneous amycretin topline results on January 24, 2025. The trial studied once-weekly subcutaneous amycretin in 125 people with overweight or obesity, with a total treatment duration of up to 36 weeks.

Novo reported an estimated body-weight loss of 9.7% with the 1.25 mg group at 20 weeks, 16.2% with the 5 mg group at 28 weeks, and 22.0% with the 20 mg group at 36 weeks, assuming participants followed the planned dosing schedule. Placebo groups gained 1.9%, 2.3%, and 2.0%, respectively.

The later Lancet subcutaneous paper added that the 60 mg dose-escalation arm showed an estimated mean body-weight change of -24.3% versus -1.1% with placebo at week 36. It also noted that 125 participants were randomly allocated, with 101 receiving amycretin and 24 receiving placebo.

While these results are notable, the trial is early-stage. The Lancet paper states that a high proportion of treatment-emergent adverse events were gastrointestinal and that a large number of participants withdrew, with many discontinuations unrelated to adverse events.

7. What Did Amycretin Show in Type 2 Diabetes?

Novo announced type 2 diabetes phase 2 results for amycretin on November 25, 2025. The trial studied once-weekly subcutaneous amycretin and once-daily oral amycretin against placebo in 448 people with type 2 diabetes inadequately controlled on metformin, with or without an SGLT2 inhibitor.

For the subcutaneous route, Novo reported HbA1c reduction up to 1.8 percentage points by week 36 from a mean baseline HbA1c of 7.8%, assuming full adherence. Up to 89.1% reached an HbA1c below 7%, and up to 76.2% reached 6.5% or lower.

For the oral route, Novo reported an HbA1c improvement of up to 1.5 percentage points from a mean baseline of 8.0%. The company reported that 77.6% reached an HbA1c below 7% and 62.6% reached 6.5% or lower with once-daily oral amycretin.

Novo reported up to 14.5% body-weight loss for subcutaneous amycretin versus 2.6% with placebo, and up to 10.1% for oral amycretin versus 2.5% with placebo. Higher doses showed no weight-loss plateau at week 36.

Note that these are company-reported phase 2 results, not data from an approved type 2 diabetes label.

8. What Is the Phase 3 Status?

Novo said in June 2025 that it would advance both subcutaneous and oral amycretin into phase 3 development for weight management after regulatory feedback and completed clinical studies. Novo planned to start the phase 3 weight-management program in the first quarter of 2026.

By the 2025 annual report, Novo was referring to the drug as zenagamtide. That report confirmed phase 3 weight-management development was underway in the first quarter of 2026 for both subcutaneous and oral formulations in obesity and diabetes.

ClinicalTrials.gov now lists AMAZE 1, NCT07339423, as a phase 3 obesity study of once-weekly subcutaneous NNC0487-0111. The record indicates the study started on February 24, 2026, has an estimated enrollment of 1,150 participants, and has an estimated primary completion date of June 26, 2029.

While phase 3 trials have started, regulatory approval remains a separate, future process.

9. Amycretin vs CagriSema

Amycretin and CagriSema both sit in the GLP-1 plus amylin category, but their designs are different. CagriSema combines two separate drugs: cagrilintide 2.4 mg and semaglutide 2.4 mg. Amycretin (zenagamtide) is a single molecule designed to activate both GLP-1 and amylin receptors.

Calling it simply “Novo’s next drug after CagriSema” misses the chemical distinction: CagriSema is a combination product, whereas zenagamtide is a single molecule.

10. Amycretin vs Semaglutide, Retatrutide, and Orforglipron

Amycretin should not be confused with semaglutide, retatrutide, or orforglipron. Semaglutide is a GLP-1 receptor agonist. Retatrutide is Lilly’s investigational triple GIP, GLP-1, and glucagon receptor agonist. Orforglipron is an oral small-molecule GLP-1 receptor agonist.

Amycretin represents a GLP-1 plus amylin approach within one molecule, actively being developed in both oral and subcutaneous forms.

This distinction matters for accurate pipeline tracking. A “GLP-1 pill” could refer to oral semaglutide, orforglipron, or oral zenagamtide. An “amylin drug” could mean Symlin, cagrilintide, CagriSema, amycretin, or another pipeline name.

For related pages, see What Is Retatrutide?, What Is Orforglipron?, and What Is Semaglutide?.

11. Summary of Amycretin/Zenagamtide Details

Tracking both the old and new names helps connect older trial publications with newer Novo materials.

In summary: amycretin (now zenagamtide) remains an investigational drug with no approved product label.

12. Amycretin FAQ

• What is amycretin in simple terms?

  Amycretin is the older name for Novo Nordisk's zenagamtide. Novo describes it as a unimolecular, long-acting GLP-1 and amylin receptor agonist being developed for subcutaneous and oral administration.

• Is amycretin now called zenagamtide?

  Yes. Novo Nordisk's 2025 annual report uses the wording zenagamtide, formerly known as amycretin. Both names matter because older trial records and newer Novo materials use different terms.

• Is amycretin FDA-approved?

  No. As of May 6, 2026, amycretin or zenagamtide is still investigational. Novo describes phase 3 development in obesity and diabetes, but there is no FDA-approved U.S. product label for amycretin or zenagamtide.

• What did oral amycretin show in phase 1?

  The 2025 Lancet oral phase 1 study enrolled 144 people with overweight or obesity. ScienceDirect's article record says all treatment-emergent adverse events were mild or moderate and that gastrointestinal events were the most common.

• What did subcutaneous amycretin show in obesity?

  Novo's January 2025 release reported estimated body-weight loss of 9.7% at 20 weeks, 16.2% at 28 weeks, and 22.0% at 36 weeks across three subcutaneous amycretin maintenance-dose groups, assuming full adherence.

13. Sources