FDA approval · New molecule55-second read
Foundayoorforglipron
Eli Lilly · GLP-1 receptor agonist · Endocrinology
Bottom line for your patients
Adults who qualify for weight management therapy have a GLP-1 receptor agonist option taken as a daily tablet. It should not be combined with another GLP-1 receptor agonist.
Drug brief
Drug IQ- Who it is for
- Adults with obesity, or adults with overweight in the presence of at least one weight-related comorbid condition, in combination with a reduced-calorie diet and increased physical activity.
- What changes
- The FDA describes it as a GLP-1 receptor partial agonist pill which does not need to be taken on an empty stomach. The supporting trials compared it with placebo.
- The evidence
- 72 weeks of treatment, with a reduced calorie diet and increased physical activity, resulted in a statistically significant and clinically meaningful reduction in body weight compared with placebo. The FDA announcement does not report the size of the reduction.Placebo-controlled randomized trialTwo trials (not named in the FDA announcement)Randomized against placebo: shows that it works, not how it compares with existing treatments.
- Watch for
- Boxed warning for thyroid C-cell tumors; not for patients with a personal or family history of medullary thyroid cancer or with Multiple Endocrine Neoplasia syndrome type 2. Warnings include pancreatitis, severe gastrointestinal reactions, acute kidney injury due to volume depletion, hypoglycemia, and acute gallbladder disease; side effects include nausea, constipation, diarrhea, and vomiting.
- How it is given
- OralOnce-daily tablet; start at 0.8 mg, increase to 2.5 mg after at least 30 days and to 5.5 mg after another 30 days; may increase further to 9 mg, 14.5 mg, or 17.2 mg
- What the approval tells you
- New molecule. An active ingredient the FDA had not approved before.