Pramlintide
Pramlintide is an injected amylin analog approved for adults with diabetes who use mealtime insulin. It is not approved for weight loss, though small obesity trials exist.
Pramlintide (known as Symlin)
Also searched as: Symlin, SymlinPen, pramlintide acetate.
Educational information. This page does not give dosing instructions or tell you what to take. Ask a prescriber about your own care.
In plain English
Pramlintide (Symlin) is an injected copy of amylin, a hormone the pancreas releases along with insulin. Amylin slows stomach emptying and helps you feel full. Pramlintide is FDA-approved as an add-on for adults with type 1 or type 2 diabetes who use mealtime insulin and are not reaching their blood sugar goals. It is not approved for weight loss.
It is in this atlas because it was the first amylin drug and a forerunner of cagrilintide, petrelintide and eloralintide. In the label's diabetes trials, people on pramlintide lost about 1 to 2 kg on average while people on placebo gained a little. In obesity trials without diabetes, a 12-month study (411 people started, 146 evaluable at 12 months) found placebo-corrected weight loss of 5.6% to 6.8% in the two best-performing groups. A different 24-week trial found that pramlintide plus phentermine reached 11.3% loss.
The label carries a boxed warning for severe low blood sugar when it is used with insulin, and the mealtime insulin dose is cut when starting. Nausea is the most common side effect, at 48% vs 17% on placebo in type 1 diabetes trials and 28% vs 12% in type 2 trials. Pramlintide is not labeled for weight loss.
Brand names and products
A generic name identifies the drug itself. A brand name identifies one company's product. One drug can come in several products with different forms and approved uses, so the brand name often tells you more about what a prescription is for.
A separate brand page for this medicine has not been added to the atlas yet. Other names on record: Symlin, SymlinPen, pramlintide acetate. The forms table below lists its approved use.
Approved and investigational. Pramlintide is FDA-approved for diabetes. Using it for weight loss goes beyond what the label describes.
How it works
Pramlintide is a synthetic version of human amylin, a hormone released by the pancreas along with insulin. It slows stomach emptying and increases fullness, so people eat less at a meal. In a small crossover study, a single injection cut the food eaten at a buffet meal by about 16% in men with obesity and 23% in men with type 2 diabetes.
Forms and approval status
| Form | How it is taken | U.S. status |
|---|---|---|
| Pramlintide injection (Symlin) | Injected under the skin before each major meal, per the label. For diabetes only, with mealtime insulin. The label cuts the mealtime insulin dose by half when starting. | Approved in the U.S. as an add-on for adults with type 1 or type 2 diabetes who use mealtime insulin and have not reached their blood sugar goals. It is not approved for obesity or weight loss. The label carries a boxed warning for severe low blood sugar. |
What the trials found
These are group averages from published trials in adults without diabetes unless stated. See how to read trial numbers before comparing.
Pramlintide with phentermine (obesity)
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 244 adults with obesity or overweight and no diabetes (88% women, average BMI 37.7), all given lifestyle counseling
- Length
- 24 weeks
- Compared with
- Placebo injections three times daily, pramlintide 120 mcg three times daily, or pramlintide plus a morning pill (sibutramine 10 mg or phentermine 37.5 mg)
- What was measured
- Average change in body weight at week 24
- Analysis approach
- Not stated in the abstract
- Other results
- Pramlintide plus sibutramine 10 mg: -11.1%. Both combinations beat pramlintide alone and placebo (P < 0.001).
- Safety
- Heart rate rose by 3.1 to 4.5 beats per minute and diastolic blood pressure by 2.7 to 3.5 mm Hg in the two combination groups. Most people stayed within normal blood pressure ranges.
- Limits
- Not fully blinded: the injection-only groups were single-blind and the combination groups were open-label. The trial was in people without diabetes, which is not the approved use of pramlintide. The pill in one combination arm is a separate drug with its own risks. Group averages do not predict one person's result.
Sources: Aronne LJ 2010
Safety
Based on the FDA-approved label for Symlin. The official label is the controlling source for warnings. The points below are a summary and may be incomplete.
Boxed warning and label notes
- Pramlintide injection (Symlin): Boxed warning: used with insulin, it raises the risk of severe low blood sugar, usually within 3 hours of an injection, especially in type 1 diabetes.
Warnings labels describe
- Boxed warning: severe low blood sugar when used with insulin. It can happen within 3 hours of an injection and can be dangerous while driving or using machinery.
- Not for people with low-blood-sugar unawareness, confirmed gastroparesis (slow stomach emptying), or a serious allergy to it.
- The mealtime insulin dose is lowered when starting, per the label, so it needs medical supervision.
Most common in trials
- Nausea (48% vs 17% on placebo in type 1 diabetes trials; 28% vs 12% in type 2)
- Reduced appetite
- Vomiting
- Headache
- Fatigue and dizziness
Less common but serious
- Severe low blood sugar (boxed warning)
What is still unknown
- How it compares with cagrilintide or other newer amylin drugs in people with obesity. No head-to-head trial is summarized here.
- Long-term weight effects. The 12-month figures count only the 146 people who stayed in the extension.
- Safety and weight loss in people without diabetes, since the label covers only people who use mealtime insulin.
Compiled from public information: FDA-approved labels, manufacturer websites, ClinicalTrials.gov and published journal articles. Sources are listed at the bottom of this page.
Sources
- Symlin (pramlintide acetate) injection: prescribing information AstraZeneca Pharmaceuticals LP, on DailyMed (U.S. National Library of Medicine). FDA-approved label. Official FDA label on DailyMed
- DailyMed: current FDA drug labels U.S. National Library of Medicine. Regulator
- Effect of pramlintide on satiety and food intake in obese subjects and subjects with type 2 diabetes Chapman I, et al. Diabetologia. 2005;48(5):838-848. PMID 15843914. Funding: Not stated in the abstract. Journal article
- Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity Smith SR, et al. Diabetes Care. 2008;31(9):1816-1823. PMID 18753666. Funding: Not stated in the abstract. Journal article
- Enhanced weight loss following coadministration of pramlintide with sibutramine or phentermine in a multicenter trial Aronne LJ, et al. Obesity (Silver Spring). 2010;18(9):1739-1746. PMID 20094043. Funding: Not stated in the abstract. Journal article