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How to Taper Off Ozempic

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At a glance

  • Taper schedule in the label / None; the label covers starting and maintenance doses only [1]
  • Approved Ozempic uses / Type 2 diabetes: glucose control, cardiovascular risk reduction, kidney outcomes; no weight-loss indication [1]
  • What the stopping trials did / Switched participants abruptly to placebo, or stopped treatment at week 68 [2][3]
  • Continued vs stopped (STEP 4) / Week 20 to 68: minus 7.9% on semaglutide vs plus 6.9% on placebo [2]
  • One year after stopping (STEP 1 extension) / Regained 11.6 of the 17.3 percentage points lost [3]
  • Ozempic label's missed-dose rule / A missed dose may be given within 5 days; after that, the label says to skip it [1]
  • With insulin or a sulfonylurea / Label says lowering that drug's dose may be needed when Ozempic starts [1]

Does the Ozempic label describe a taper?

The dosing section builds the dose upward and stops there. The starting dose is 0.25 mg once weekly, which is not a maintenance dose; after 4 weeks it goes to 0.5 mg, and if more glycemic control is needed, to 1 mg after at least 4 weeks on 0.5 mg, then to 2 mg after at least 4 weeks on 1 mg, with 2 mg the weekly maximum [1]. For the kidney indication the step is to 1 mg after at least 4 weeks on 0.5 mg [1].

The label's scheduling instructions are a missed-dose rule (a missed dose may be given within 5 days of the scheduled one; after that, the label says to skip it) and permission to change the weekly dosing day if doses are more than 48 hours apart [1]. Neither is a taper schedule.

What the trials did when semaglutide stopped

STEP 4 was a withdrawal trial. After a 20-week run-in on semaglutide 2.4 mg weekly (mean loss 10.6%), 803 adults with overweight or obesity and no diabetes were randomized to keep taking 2.4 mg (535 people) or switch to placebo (268 people) for 48 weeks. From week 20 to week 68, the continuing group lost a further 7.9% of body weight while the placebo group gained 6.9%, a 14.8 percentage point difference [2]. Participants switched to placebo rather than stepping down.

The STEP 1 extension followed 327 participants for a year after treatment stopped. Mean loss at week 68 was 17.3% on semaglutide versus 2.0% on placebo; a year off treatment, the semaglutide group had regained 11.6 percentage points, leaving a net loss of 5.6% versus 0.1%, and most cardiometabolic improvements moved back toward baseline [3].

Both studies used semaglutide 2.4 mg weekly in adults with overweight or obesity and no diabetes [2][3], not Ozempic's labeled diabetes doses of 0.5, 1 and 2 mg [1].

Frequently asked questions

Can Ozempic be stopped abruptly?
The label covers starting and maintenance dosing plus a missed-dose rule; it sets out no stopping plan [1]. In STEP 4, adults on semaglutide 2.4 mg switched straight to placebo, and from week 20 to week 68 they gained 6.9% while those who continued lost a further 7.9% [2].
Would tapering prevent weight regain?
Neither withdrawal trial tested a taper, so whether tapering changes weight regain is not known. In the STEP 1 extension, participants regained 11.6 of the 17.3 percentage points they had lost within a year after treatment stopped [3], and in STEP 4 weight rose 6.9% after the switch to placebo versus a further 7.9% loss on continued semaglutide [2].
Does the label say anything about how long semaglutide stays in the body?
The Ozempic label refers to a long washout period for semaglutide and says to discontinue at least 2 months before a planned pregnancy [1].
Is Ozempic approved for weight loss?
No. It is approved for glucose control in type 2 diabetes, for reducing major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and for kidney outcomes in adults with type 2 diabetes and chronic kidney disease [1].

References

  1. U.S. National Library of Medicine, DailyMed. Ozempic injection (Novo Nordisk) prescribing information. Ozempic injection (Novo Nordisk) label
  2. Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021;325(14):1414-1425. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial
  3. Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022;24(8):1553-1564. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension
  4. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA
Evidence overview for How to Taper Off Ozempic