Novo Nordisk is seeking FDA approval for an experimental obesity shot, CagriSema (cagrilintide and semaglutide), according to a Dec. 18 news release from the Denmark-based drugmaker.
CagriSema is a weekly injection of semaglutide, a GLP-1, and cagrilintide, a long-acting amylin analogue. If approved, the drug would be the first injectable GLP-1 and amylin analogue combination treatment.
In a phase 3 trial of 3,417 adults with obesity or overweight with at least one obesity-related complication, those who took CagriSema achieved an average weight loss of 20.4% after 68 weeks. The placebo group averaged a 3% reduction in weight, according to the release.
Novo Nordisk said it expects the FDA to review the CagriSema application in 2026.
Here are four other GLP-1 updates:
1. On Dec. 18, Eli Lilly said a phase 3 trial for orforglipron, its experimental daily GLP-1 pill for obesity, helped patients maintain weight loss in a first-of-its-kind trial.
The phase 3 trial is unique because it evaluated weight maintenance among study participants who first received injectable doses of GLP-1s approved for obesity — Novo Nordisk’s Wegovy (semaglutide) or Eli Lilly’s Zepbound (tirzepatide) — before receiving orforglipron or a placebo.
One year after receiving Wegovy for 72 weeks and then orforglipron, participants “maintained their previously achieved weight loss” with an average weight gain of 2 pounds, Eli Lilly said. For Zepbound and orforglipron, the average weight gain was about 11 pounds.
The company said it has filed for FDA approval of orforglipron.
2. Another experimental Eli Lilly drug, retatrutide, delivered an average 28.7% weight loss and reduced pain at its 12-milligram dose. The 68-week trial recruited 445 adults with obesity or overweight and knee osteoarthritis.
Retatrutide is a glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon triple-hormone receptor agonist — a new medication class with greater weight loss potential than GLP-1s such as Wegovy or GLP-1-GIPs such as Zepbound.
Eli Lilly said it expects additional trial results in 2026.
3. Pfizer recently made a play to enter the lucrative GLP-1 industry, which has been dominated by Novo Nordisk and Eli Lilly. On Dec. 9, the company agreed to a deal with YaoPharma for YP05002, a small-molecule GLP-1 receptor agonist in phase 1 development for chronic weight management.
Pfizer will pay $150 million up front and may pay up to $1.935 billion for development, regulatory and commercial milestones.
Four weeks earlier, the drugmaker said it plans to acquire Metsera in a deal which could exceed $10 billion, after tussling with Novo Nordisk to acquire the clinical-stage obesity drugmaker.
4. A study conducted by researchers at Cambridge, Mass.-based Harvard University found GLP-1s might have a minimal effect on a person’s risk of developing some obesity-related cancers.
The research, published Dec. 9, analyzed 48 randomized controlled trials involving 94,245 participants who had Type 2 diabetes, obesity or were overweight.
With “moderate certainty,” the researchers said the GLP-1 drugs had “little or no effect” on an individual’s risk of developing thyroid, breast, pancreatic or kidney cancer. The researchers were less certain on how GLP-1s could reduce someone’s risk of developing nine other obesity-related cancers — colorectal, endometrial, esophageal, liver, gallbladder, gastric, multiple myeloma, meningioma or ovarian, multiple myeloma or meningioma.
