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Semaglutide vs CagriSema

It is the shot behind Ozempic and Wegovy, used for diabetes and weight loss. Trials in tens of thousands of people show about 15% weight loss and fewer heart attacks. A weekly weight-loss shot that combines two hormones. Large trials show about 20% weight loss over 68 weeks, but it is not yet approved.

Both sit at grade A: strong human evidence. Semaglutide: FDA approved. CagriSema: In clinical trials.

Evidence

AStrong human evidence
AStrong human evidence

Human studies cited

11
4

Animal or cell studies cited

0
0

Why the grade

Semaglutide has one of the largest trial programs of any peptide: the STEP trials in obesity (STEP 1, 1,961 adults), the SUSTAIN trials in type 2 diabetes, SELECT (17,604 adults with cardiovascular disease and obesity, the largest), FLOW in kidney disease, and systematic reviews pooling tens of thousands of participants. Weight loss, glucose lowering and reductions in heart attack, stroke and kidney outcomes are all shown in randomized placebo-controlled trials. What remains open is what happens over decades and how to stop without regaining.
Two large phase 3 randomized placebo-controlled trials support the weight-loss use: REDEFINE 1 randomized 3,417 adults with overweight or obesity and REDEFINE 2 randomized 1,206 adults with type 2 diabetes, both over 68 weeks. A thorough QT study (105 participants) and a phase 2 trial of cagrilintide alone round out the human data. What is missing is regulatory approval and long-term outcome data beyond 68 weeks.

FDA

FDA approved

Semaglutide is FDA-approved as Ozempic (weekly injection, type 2 diabetes, 2017; with later indications to reduce cardiovascular events and, since January 2025, kidney disease progression in type 2 diabetes), Rybelsus (daily tablet, type 2 diabetes, 2019), and Wegovy (weekly injection, chronic weight management, 2021; cardiovascular risk reduction in obesity, 2024; MASH with liver fibrosis, 2025; an oral Wegovy tablet, December 2025). Compounded semaglutide is not FDA-approved.

In clinical trials

CagriSema is not approved by the FDA for any use as of 2026-10-26. Novo Nordisk reported submitting it to the FDA for weight management, and the application is under review; no product name has been approved.

Sold for

Semaglutide is the GLP-1 injection behind Ozempic and Wegovy, the most talked-about weight loss drug of the decade.
CagriSema is talked about as the next step after semaglutide: a weekly injection combining two hormones that early company statements suggested could beat tirzepatide on weight loss.

Studies say

Randomized trials in tens of thousands of people show about 15 percent weight loss, roughly a 1 to 2 point HbA1c reduction, a 20 percent cut in major cardiovascular events and slower kidney decline, with gastrointestinal side effects and weight regain after stopping as the main caveats.
Published phase 3 trials show roughly 20% body-weight loss over 68 weeks against 3% on placebo, which earns an A for the weight-loss use, but the head-to-head trial against tirzepatide missed its primary goal.

Class

GLP-1 receptor agonist
Amylin + GLP-1 combination

Route

Several routes
Injection