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Amylin Analogs: What the Class Has Actually Shown

Amylin is the second satiety lever, and one analog of it has ever been approved in the United States — pramlintide, which produced 3.7% placebo-corrected weight loss over 16 weeks and is now recorded as discontinued. The unapproved analogs report up to 20%.

Owen Castellanos10 min read
One receptor, one approval, a fivefold spreadWeight change with an amylin analog given alone, by trialPramlintide, 16 wk3.7% vs placeboPetrelintide, 16 wk8.6% from baselineCagrilintide, 26 wk10.8% from baselineEloralintide, 48 wk20% from baselineSeparate trials. The first bar is placebo-corrected, the rest are not.Nausea did not fall as weight loss roseEloralintide: 64% at 6 mg, 33% at 9 mg, 14% on placeboThe one approved amylin analog is discontinuedAll three pramlintide products, and no generic behind themNo amylin analog has published a phase 3 monotherapy result.

Amylin is a hormone the pancreatic beta cell releases alongside insulin after a meal. It slows gastric emptying, suppresses glucagon, and ends eating episodes through a route that has nothing to do with the incretin receptors described in the mechanism article. The effect on meal size is rapid and short-lasting, tracks the meal-induced rise in circulating amylin, and is mediated centrally rather than by peripheral receptors, with the area postrema in the caudal hindbrain identified as a key site.[1] That is a second satiety lever, and the entire commercial interest in this class rests on the premise that pulling it does something the first lever does not.

The receptor has been drugged before. What that attempt produced, and how far it sits from the figures now attached to the word amylin, is the most useful thing in the published record.

The approved one, and what it actually did

Pramlintide is a synthetic 37-amino-acid polypeptide that differs from human amylin by the replacement of three residues with proline, at positions 25, 28 and 29.[7] It was approved as an adjunct to insulin, not as a weight drug, and the obesity question was tested separately.

A phase 2 trial randomized 204 adults with obesity, with and without type 2 diabetes and none of them on insulin, to pramlintide at up to 240 mcg three times daily before meals or to placebo for 16 weeks, with no concomitant lifestyle intervention. Placebo-corrected weight reduction was 3.7 ± 0.5% (3.6 ± 0.6 kg; P < 0.001) and waist circumference fell 3.6 ± 1.1 cm (P < 0.01). About 31% of treated participants reached a 5% reduction against 2% on placebo, and 88% managed the escalation to the top dose.[2]

A longer trial randomized 411 adults with obesity across six pramlintide regimens or placebo alongside a structured lifestyle program for four months, with an eight-month extension. Placebo-corrected loss at month 4 was 3.1 ± 1.1% at 120 mcg three times daily and 3.1 ± 1.0% at 360 mcg twice daily; by month 12 those figures were 5.6 ± 2.1% and 6.8 ± 2.3%, with 40% and 43% of participants reaching a 10% reduction against 12% on placebo.[3]

The denominator is the part worth holding. Those 12-month figures rest on 146 evaluable participants out of 411 randomized — roughly two in three people are not in the number.[3] It is the same problem that shadows every long obesity trial, and it is why an estimand that counts only the people who stayed reads higher than one that counts everybody.

Nausea was not the mechanism, and the trial says so

The folk explanation of this entire drug class is that people eat less because they feel sick. The 16-week pramlintide trial reported the test directly: participants who did not report nausea lost 3.6 ± 0.5% of body weight and participants who did lost 3.9 ± 0.5%.[2] Those are indistinguishable. Whatever amylin agonism is doing to appetite, it is not operating through making people queasy, and the same distinction between a side effect and a mechanism is drawn in the nausea article.

What the register says about the only approval

All three pramlintide products sit under a single application, 021332, approved in March 2005 and September 2007. The Orange Book product file records every one of them with a marketing status of discontinued, and no abbreviated application for pramlintide appears anywhere in that file.[8] Drugs@FDA returns the same status.

So the position of this class, stated plainly: one molecule has ever been approved against the amylin receptor in the United States, it produced single-digit weight reduction on a three-times-daily schedule, and it is no longer marketed. Everything else discussed under the word amylin is in development. What that phrase does and does not mean is the subject of the approval-status article.

The long-acting analogs, given alone

Cagrilintide is the one with the largest monotherapy trial. A dose-finding phase 2 at 57 sites in ten countries randomized 706 adults without diabetes 6:1 to weekly cagrilintide at 0.3, 0.6, 1.2, 2.4 or 4.5 mg, to once-daily liraglutide 3.0 mg, or to placebo for 26 weeks. On the trial product estimand, weight reduction ran from 6.0% at the bottom dose to 10.8% (11.5 kg) at 4.5 mg against 3.0% (3.3 kg) on placebo.[4]

The active comparator is the number that matters. Cagrilintide 4.5 mg against liraglutide 3.0 mg was 10.8% against 9.0% — an estimated treatment difference of 1.8 percentage points, p = 0.03.[4] A new weekly molecule beat a daily one that had been on pharmacy shelves since 2014 by under two points, which is the comparison covered from the other side in the liraglutide article. Permanent discontinuation ran 10% across groups, 4% of it for adverse events.[4]

Eloralintide is a selective amylin receptor agonist and the only analog with a 48-week randomized monotherapy result in print. A phase 2 trial randomized 263 adults at 46 United States centers to placebo or to weekly eloralintide at 1, 3, 6 or 9 mg, or to escalations of 6–9 mg or 3–9 mg. Mean weight change on the efficacy estimand was −9% (95% CI, −12.6 to −6.3) at 1 mg, −12% (−14.9 to −9.8) at 3 mg, −18% (−20.7 to −14.5) at 6 mg and −20% (−22.7 to −17.5) at 9 mg, against −0.4% (−2.2 to 1.4) on placebo.[5]

Petrelintide has only phase 1 data. Two randomized, placebo-controlled trials covered single doses from 0.04 to 2.4 mg and sixteen weekly doses escalated to targets of 2.4, 4.8 and 9.0 mg. Body weight fell by up to 8.6% after 16 weeks, the half-life ran about 10 days, nausea occurred in 16.7% to 33.3% of petrelintide recipients against 16.7% on placebo in the multiple-dose part, and one participant discontinued for gastrointestinal events.[6] That is a tolerability signal from a study designed to produce one, in a sample sized for safety rather than for effect.

The tolerability claim, tested against its own numbers

This class is marketed on being easier to take than the incretins, and the mechanistic case for that is real: receptor selectivity, exposure kinetics and whether a compound also engages the calcitonin receptor may determine whether reduced eating reflects physiological satiation or aversive signaling, and those properties differ compound by compound.[9] The class-level generalization is what the data do not support.

In the eloralintide trial, nausea ran 11% at 1 mg, 13% at 3 mg, 64% at 6 mg, 33% at 9 mg, 54% on the 6–9 mg escalation and 25% on the 3–9 mg escalation, against 14% on placebo.[5] The dose with less weight loss had roughly twice the nausea of the dose with more. The 6 mg arm held 28 people, so the figure is unstable, but the shape of it is the point: nausea did not track dose, and the schedule that reached the top dose gradually reported less of it than the one that sat at 6 mg.

Fatigue moved the other way and moved steadily: 0% at 1 mg, 13% at 3 mg, 29% at 6 mg and 43% at 9 mg, against 12% on placebo.[5] Two in five people on the top dose reported it. Fatigue on these drugs is covered in the fatigue article, and a 43% rate is not a footnote to a 20% weight figure.

Where the field is, with the certainty attached

A 2026 network meta-analysis pooled six trials and 4,642 participants across 12 to 68 weeks. It ranked high-dose subcutaneous amycretin first at −23.95% against placebo, high-dose eloralintide second at −18.01% and high-dose cagrilintide-semaglutide third at −17.18%, all ahead of semaglutide 2.4 mg at −11.45% and liraglutide 3.0 mg at −6.4%. Gastrointestinal events, nausea, vomiting and constipation were all more common with the high-dose amylin-based arms, and only high-dose cagrilintide-semaglutide increased discontinuation for adverse events. The authors describe the network as sparse and low-certainty and the findings as preliminary.[10] Six trials is a hypothesis about what to test next, not a ranking to prescribe from.

Three absences define the rest. No amylin analog has published a phase 3 monotherapy result, so every figure above comes from phase 1 or phase 2. No cardiovascular outcome result exists for any of them. And no amylin analog other than pramlintide has ever held a United States approval, which means none of the newer ones has an approved dose, an approved indication or a contraindication list. The combination route — amylin plus a GLP-1 agonist, either as two molecules or as one — is where the larger figures come from, and it is covered in the CagriSema article and the amycretin article.

What a vial sold under one of these names would be

Because no long-acting amylin analog is a component of any FDA-approved drug, no pharmacy is preparing one against an approved reference. Compounded preparations in general are not FDA-approved, and the FDA does not review them for safety, efficacy or quality before they are dispensed. For a substance with no approved product anywhere in the country, there is additionally no label to check a concentration against and no reference standard to compare a sample with.

The practical consequence is that a purity claim about one of these peptides is an assertion rather than a finding. How figures on this site are established before publication is described in the methodology.

Frequently asked

What does amylin do that a GLP-1 drug does not?
Amylin is co-secreted with insulin after a meal and ends eating episodes through a central route, with the area postrema in the caudal hindbrain identified as a key site. It also slows gastric emptying and suppresses glucagon. The effect on meal size is rapid and short-lasting and is mediated by humoral action in the brain rather than by peripheral receptors, which makes it a separate lever from incretin receptor agonism.
Is any amylin analog approved in the United States?
One has been: pramlintide, a 37-amino-acid synthetic polypeptide approved as an adjunct to insulin. All three of its products sit under a single application and the Orange Book product file records every one of them as discontinued, with no abbreviated application behind them. Cagrilintide, eloralintide and petrelintide have no record in Drugs@FDA at all.
How much weight did amylin analogs produce on their own?
The range is wide and the trials are not comparable. Pramlintide produced 3.7% placebo-corrected loss over 16 weeks and roughly 5.6% to 6.8% at twelve months. Cagrilintide 4.5 mg gave 10.8% over 26 weeks against 3.0% on placebo. Eloralintide gave about 20% at 9 mg over 48 weeks against 0.4% on placebo. Petrelintide gave up to 8.6% over 16 weeks in a phase 1 study.
Are amylin analogs better tolerated than GLP-1 drugs?
That is the class's selling point and the published data complicate it. In the eloralintide phase 2, nausea ran 64% at 6 mg and 33% at 9 mg against 14% on placebo, so it did not track dose, and the 6 mg arm held only 28 people. Fatigue did track dose, reaching 43% at 9 mg against 12% on placebo. Petrelintide's phase 1 reported nausea in 16.7% to 33.3% against 16.7% on placebo.
Do these drugs work by making people nauseated?
The one trial that tested this directly says no. In the 16-week pramlintide study, participants who reported no nausea lost 3.6 ± 0.5% of body weight and those who did lost 3.9 ± 0.5% — an indistinguishable difference. Weight reduction on that molecule was not carried by the people who felt sick.
How far along is the class?
No amylin analog has published a phase 3 monotherapy result, and none has a cardiovascular outcome result. A 2026 network meta-analysis that ranked the class pooled six trials and 4,642 participants and described its own network as sparse and low-certainty and its findings as preliminary. Every figure in print for the newer analogs comes from phase 1 or phase 2.

Sources

  1. [1] Lutz TA (2025). Role of amylin in feeding and satiation. Neuropharmacology. PMID 40639451
  2. [2] Aronne L, Fujioka K, Aroda V, et al. (2007). Progressive reduction in body weight after treatment with the amylin analog pramlintide in obese subjects: a phase 2, randomized, placebo-controlled, dose-escalation study. J Clin Endocrinol Metab. PMID 17504894
  3. [3] Smith SR, Aronne LJ, Burns CM, et al. (2008). Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. PMID 18753666
  4. [4] Lau DCW, Erichsen L, Francisco AM, et al. (2021). Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. PMID 34798060
  5. [5] Billings LK, Hsia S, Bays H, et al. (2025). Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. PMID 41207310
  6. [6] Brændholt Olsen M, Griffin J, Hövelmann U, et al. (2026). Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials. Diabetes Obes Metab. PMID 42017294
  7. [7] U.S. Food and Drug Administration (2026). SymlinPen (pramlintide acetate) injection — prescribing information, Description section, via the openFDA drug label endpoint. FDA / DailyMed structured product labeling. Source
  8. [8] U.S. Food and Drug Administration (2026). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) — product data file, data as of September 11, 2026: pramlintide acetate application 021332, all products discontinued; no abbreviated application. FDA Orange Book. Source
  9. [9] Fischer SL, Borner T (2026). Beyond GLP-1: Amylin-based pharmacotherapy and the search for better-tolerated weight-loss drugs. Pharmacol Res. PMID 42586227
  10. [10] Kamrul-Hasan ABM, Khalil I, Mahajan K, et al. (2026). Novel Amylin-Based Therapies for Weight Management in Adults With Overweight or Obesity Without Diabetes: A Network Meta-Analysis. Endocrinol Diabetes Metab. PMID 42175595

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