๐Ÿš€ Phase 3 ๐Ÿ’Š Pill + Injection Novo Nordisk ยท Two formulations

Amycretin

NNC0487-0045 ยท GLP-1 + Amylin Unimolecular ยท Est. FDA: 2028-2029

Amycretin is the world's first GLP-1/amylin single molecule, and it comes in both forms: a weekly injection showing 22% weight loss, and a daily oral pill showing 13.1%. Both are in Phase 3. Only one other oral weight loss pill exists.

The only weight loss drug available in both a pill and an injection. The injection showed 22% weight loss and the oral pill showed 13.1% in early trials. Both formulations are now in Phase 3.

๐Ÿ’Š
Injection Loss
22%
Est. FDA
2028-29
At a Glance

Amycretin by the Numbers

Injection Weight Loss
22%
Phase 1b/2a at 36 weeks (Lancet)
Oral Pill Weight Loss
13.1%
Phase 1 at 12 weeks, oral pill
Mechanism
GLP-1 + Amylin
Single unimolecular combination
Available Formulations
Pill + Injection
Both in Phase 3 simultaneously
Manufacturer
Novo Nordisk
Makers of Wegovy and Ozempic
FDA Status
Phase 3
Both formulations started Q1 2026
Plain English

What Exactly Is Amycretin?

A single molecule that combines GLP-1 and amylin, in both a pill and an injection form. Amycretin is Novo Nordisk's next leap beyond Wegovy: instead of GLP-1 alone, it combines GLP-1 with amylin in a single molecule, and it's being developed as both a daily oral pill and a weekly injection simultaneously.

Amycretin is a unimolecular GLP-1/amylin combination, meaning both mechanisms are built into a single compound, not two separate drugs given together. This is chemically different from CagriSema (Novo's other combination drug), which is two separate molecules co-administered.

Amylin is a hormone released alongside insulin after meals. It helps regulate blood sugar and slows gastric emptying, reinforcing the appetite-suppressing effects of GLP-1 from a different angle. Combining them in one molecule may improve potency and reduce side effects compared to using either alone.

What makes Amycretin uniquely ambitious: Novo Nordisk is developing both a weekly injectable and a daily oral pill in parallel through Phase 3. The oral pill formulation could become only the second-ever oral weight loss pill (after Rybelsus), and potentially a far more effective one.

The Dual Mechanism

GLP-1 + Amylin in One Molecule

Two appetite-regulating hormones combined into a single drug, in pill or injection form. Each hormone targets a different aspect of appetite and metabolism. Together in one molecule, they produce stronger and potentially more durable results.

๐Ÿ’‰
Weekly Injection
Subcutaneous injection once a week. Phase 1b/2a published in The Lancet showed 22% weight loss at 36 weeks, comparable to or exceeding the best approved drugs. Phase 3 began Q1 2026.
๐Ÿ’Š
Daily Oral Pill
Taken once daily as a tablet. Phase 1 showed 13.1% weight loss at 12 weeks, already exceeding many approved injectables at a much earlier stage. Phase 3 also began Q1 2026, making this the most advanced oral GLP-1 pill in development.
1

GLP-1: Appetite Suppression

The GLP-1 component signals fullness to the brain, slows gastric emptying, and reduces hunger hormones. This is the same mechanism as Wegovy, but here it's paired with a second appetite-regulating hormone in one molecule for amplified effect.

2

Amylin: Reinforced Satiety

Amylin is a pancreatic hormone that works alongside insulin to slow gastric emptying and suppress appetite through different brain pathways than GLP-1. Combining both in one molecule targets appetite from two independent angles simultaneously.

3

Choice of Delivery Method

Uniquely, patients may eventually be able to choose between a weekly injection or a daily oral pill, depending on which Phase 3 formulation earns FDA approval. This flexibility could significantly expand who's able to benefit from the drug.

Clinical Trial Data

What the Trials Showed

Injection: 22% at 36 weeks (Lancet). Oral: 13.1% at 12 weeks. Both in Phase 3. Early-phase data for both amycretin formulations has been published, painting an unusually clear picture of a drug's potential before Phase 3 is even complete.

22%
Injection, Phase 1b/2a
At 36 weeks, published in The Lancet
13.1%
Oral Pill, Phase 1
At only 12 weeks, exceptionally early
๐Ÿ“Š Why 13.1% at 12 Weeks Is Remarkable

The 13.1% oral pill result is notable for two reasons: it was from a Phase 1 trial (typically the smallest, shortest study), and it was measured at only 12 weeks. For reference, Wegovy (a weekly injection) shows about 15% at 68 weeks. An oral pill achieving 13.1% at just 12 weeks, before the dose is fully optimized and before any weight loss plateau, suggests substantially higher potential at longer durations in Phase 3.

โ„น๏ธ Injection data: Phase 1b/2a trial published in The Lancet. Oral data: Phase 1 trial. Both formulations entered Phase 3 in Q1 2026. Phase 3 will provide the definitive efficacy and safety data for both FDA submissions.
Development Timeline

Where Things Stand

Both formulations in Phase 3 since Q1 2026. FDA decision expected 2028-2029. Novo Nordisk is running Phase 3 programs for both the injection and oral formulations simultaneously. This is an unusually broad development program.

2022-2024
โœ“ Done
Phase 1 / 1b/2a, Both formulations
Injection Phase 1b/2a: 22% weight loss at 36 weeks (published in The Lancet). Oral Phase 1: 13.1% weight loss at 12 weeks. Both confirmed safe and effective enough to proceed to Phase 3.
Q1 2026, Now
โ— Happening Now
Phase 3, Both formulations simultaneously
Novo Nordisk launched Phase 3 trials for both the weekly injection and the daily oral pill at the same time in early 2026. This parallel approach is unusual and signals Novo's confidence in the drug.
Est. 2027-2028
Up Next
Phase 3 Results
Phase 3 data readouts expected for both formulations. The oral pill results in particular will be closely watched, if confirmed at Phase 3 scale, it would be a major milestone for obesity treatment access.
Est. 2028-2029
Up Next
NDA Filing + FDA Decision
Novo Nordisk files for FDA approval. One or both formulations could be approved, potentially making amycretin the only drug available as both a pill and an injection. FDA decision expected 2028-2029.
๐Ÿ’ก Want to try it before approval?

Phase 3 trials for both the injection and oral pill formulations are now enrolling. Participants receive amycretin at no cost under close medical supervision.

Search Open Trials โ†’
Quick facts
Formulations in Phase 3 2 (pill + inj.)
Phase 3 started Q1 2026
Injection trial length 72 weeks
Injection Phase 2 published The Lancet

"I've been running trials long enough to know that early data doesn't always hold. But the lean mass numbers in amycretin's early readouts were different from what we typically see in this drug class, and that's worth following carefully."

Dr. Humberto Fernandez-Miro, MD

Dr. Humberto Fernandez-Miro, MD

Family Medicine ยท Clinical Research

Who Should Watch This

Is Amycretin Right for You?

Not available yet. Here's who it looks best suited for when it is. Amycretin isn't approved yet, but its dual-formulation strategy opens it up to a broader potential audience than most pipeline drugs. Here's who it looks most promising for.

โœ… Likely Good Candidates

  • Anyone who prefers a pill over an injection, the oral formulation could work well for patients who prefer to avoid injections
  • Adults with BMI 30+ looking for a highly effective option with Novo Nordisk's track record (Wegovy, Ozempic)
  • People who've tried other GLP-1 drugs and want to try a different mechanism pairing
  • Patients interested in the highest-efficacy oral option, 13.1% at 12 weeks in Phase 1 is remarkable
  • People willing to wait for a 2028-2029 approval for potentially the most flexible and powerful option available

โš ๏ธ Things to Consider

  • Not FDA-approved, still 2-3 years away at minimum
  • The oral pill's 13.1% was at 12 weeks in Phase 1, results at Phase 3 scale and longer duration may differ
  • The injection 22% was from Phase 1b/2a, Phase 3 results may be slightly different as trial populations expand
  • Anyone who needs treatment now should start Wegovy or Zepbound, they're proven and available today
  • Both formulations need to complete Phase 3 separately, one could succeed even if the other has setbacks
Head to Head

How Amycretin Stacks Up

Amycretin vs. approved drugs and other pipeline options. Amycretin's combination of a highly effective injection and a promising oral pill option makes it one of the most versatile pipeline drugs, especially for patients who can't or won't inject.

Drug Mechanism Best Weight Loss Dosing Options Status
๐Ÿ’Š๐Ÿ’‰Amycretin GLP-1 + Amylin (unimolecular) 22% injection / 13.1% pill Daily pill or weekly injection Phase 3
๐Ÿ’‰Wegovy GLP-1 Agonist 15% Weekly injection FDA Approved
๐Ÿ’‰Zepbound GLP-1 + GIP Agonist 20-21% Weekly injection FDA Approved
๐Ÿ’‰Retatrutide GLP-1 + GIP + Glucagon 24.2% Weekly injection Phase 3
๐Ÿ’ŠRybelsus GLP-1 Agonist 5% Daily pill FDA Approved

Amycretin's oral 13.1% at 12 weeks compares favorably even to approved weekly injectables. All figures from Phase 1/2 trial publications. Approved drug figures from FDA-approved prescribing information.

Common Questions

Amycretin FAQ

Great question, they share a similar concept but are molecularly very different. CagriSema is a co-formulation of two separate molecules: semaglutide (GLP-1) and cagrilintide (amylin analog), given together in a single injection. Amycretin is a true unimolecular design, GLP-1 and amylin activity are built into a single compound. This structural difference may affect potency, side effects, and how the body processes the drug. Amycretin also uniquely comes in both a weekly injection and a daily oral pill, while CagriSema is injection-only.
Two main reasons. First, amycretin combines GLP-1 and amylin in one molecule, it's not just semaglutide in pill form. The dual mechanism is more powerful than GLP-1 alone. Second, Rybelsus uses an older oral delivery technology (SNAC) that limits absorption. Novo Nordisk used more advanced formulation technology for amycretin's oral version, improving how much of the active drug reaches the bloodstream. The 13.1% at 12 weeks is from Phase 1, Phase 3 will determine if that advantage holds at larger scale and longer duration.
Many people strongly prefer to avoid injections, needle phobia is common, and the convenience of a daily pill fits more naturally into many people's routines than a weekly self-injection. The oral pill at 13.1% at 12 weeks already outperforms some approved injectables at full duration. Even if the final oral Phase 3 result comes in at 15-18%, many patients would choose the pill over an injection that produces 20-22%, especially if the difference in outcomes isn't clinically significant for their situation.
It depends on what you value. Retatrutide and CT-388 have higher Phase 2 weight loss numbers (24.2% and 22.5% respectively). But amycretin has a distinct mechanism (GLP-1 + amylin) and the unique advantage of coming in both an oral pill and an injection. For patients who want or need the oral option, amycretin may be the best available choice when approved. For patients who are fine with injections and want maximum weight loss, retatrutide or CT-388 may outperform. Phase 3 data will help clarify each drug's true positioning.
Early-phase data showed a side effect profile consistent with other GLP-1 class drugs: predominantly gastrointestinal effects including nausea, vomiting, diarrhea, and constipation, mostly during the dose-escalation period. The unimolecular GLP-1/amylin design was developed partly to reduce side effects versus combining two separate drugs. Full safety characterization will come from Phase 3 in both formulations.
Yes, both the injection and oral pill Phase 3 trials launched in Q1 2026 and are actively enrolling. This is a unique opportunity to potentially get access to the oral pill formulation before any drug of its kind has been approved. Search for "amycretin" or "NNC0487-0045" on ClinicalTrials.gov to find open trials near you. Participants receive the drug at no cost with close medical supervision.
Dr. Fernandez-Miro
Medically Reviewed by
Dr. Fernandez-Miro
Obesity Medicine