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CagriSema Phase 3 Trials Expand Into Children and a New Dose Comparison

August 31, 2026 · 4 sources · 5 min read

From above of crop anonymous plump female doctor in disposable gloves working at table with paper on clipboard — Illustration accompanying coverage of the CagriSema phase 3 trials registry update from Novo Nordisk — Photo: Laura James / Pexels

ClinicalTrials.gov records reviewed on August 31, 2026 show the CagriSema phase 3 trials program has widened to include adolescents and a head-to-head comparison of two CagriSema dose levels against semaglutide alone. For anyone already tracking a semaglutide protocol, this is the clearest signal yet of what the next generation of injectable obesity medicines is being tested to do.

Novo Nordisk's CagriSema phase 3 program now spans multiple registered trials, including a newly recruiting 460-participant study in children and adolescents (NCT07253285) and a 2,500-participant adult trial comparing two CagriSema doses against semaglutide (NCT07564414). CagriSema combines semaglutide with the amylin analogue cagrilintide and is still investigational, not available by prescription.

The short version

A newly recruiting phase 3 trial (NCT07253285) will enroll 460 children and adolescents with excess body weight, randomizing them to CagriSema, cagrilintide, semaglutide or placebo.
A second recruiting phase 3 trial (NCT07564414) plans to enroll 2,500 adults with obesity, with or without type 2 diabetes, and compares two CagriSema dose levels against semaglutide over roughly 83 weeks.
The large 3,400-participant phase 3 study NCT05567796 is now listed as active but no longer recruiting, with an extension phase that follows participants after study medicine stops.
A completed 18-participant phase 1 study (NCT06716307) compared blood levels of cagrilintide and semaglutide delivered from two different versions of injectable CagriSema.
Novo Nordisk's own registry text states CagriSema is still being tested and is not yet available for doctors to prescribe.

What is CagriSema, and why do the phase 3 trials matter?

CagriSema is an investigational once-weekly injection that combines two molecules in a single product. One is semaglutide, the GLP-1 receptor agonist already marketed for type 2 diabetes and for weight management. The other is cagrilintide, a long-acting analogue of amylin, a hormone co-secreted with insulin that acts on the brain to influence satiety and meal size. Neither cagrilintide alone nor the combination is currently available by prescription.

That combination is the reason the program draws attention from people already using a GLP-1. Semaglutide and tirzepatide both work primarily through incretin receptors. Amylin is a different pathway, and pairing it with a GLP-1 is the leading industry bet on getting further weight reduction without simply pushing incretin exposure higher. The phase 3 trial designs registered by Novo Nordisk are built to isolate exactly that question.

Phase 3 is the stage at which a sponsor tests a candidate at scale against a comparator, generating the efficacy and safety data regulators use to decide on approval. The registry records reviewed on August 31, 2026 show a program that has grown well past a single pivotal study into a set of trials covering adults, adolescents, dose selection, and device formulation.

The new pediatric CagriSema trial: 460 children and adolescents

The most consequential new entry is NCT07253285, a phase 3 study listed as recruiting with a planned enrollment of 460 children and adolescents with excess body weight. According to the registry record, participants are randomized to CagriSema, to cagrilintide alone, to semaglutide, or to placebo, with treatment assignment decided by chance. Semaglutide is included as a comparator because, as the record notes, it is already prescribable for adolescents and adults.

The design has two parts. The main study runs about a year and six months. Participants who received semaglutide in the main study do not continue into the extension, while those who do continue receive either CagriSema or cagrilintide, bringing total participation to roughly four years and ten months. That length matters: pediatric obesity pharmacotherapy has been criticized for short follow-up, and a near-five-year window is unusual.

The registry text is explicit that, like all drugs, the study drugs may have side effects, and it does not claim a benefit. Nothing in the record establishes that CagriSema works better than semaglutide in this age group — that is the question the trial exists to answer, and the answer will not exist until the data are analyzed and published.

Since semaglutide is the active comparator in every one of these trials, readers already on it may find our semaglutide dosage calculator useful for keeping their own record consistent while the combination data mature.

The four-arm phase 3 record shows a planned enrollment of 3,400 participants and an extension phase in which selected participants receive no study medicine while investigators follow their body weight. the four-arm phase 3 record.

A second adult phase 3 trial compares two CagriSema dose levels

The other newly recruiting study, NCT07564414, plans to enroll 2,500 adults living with obesity, with or without type 2 diabetes. Its stated purpose is to determine how safe and effective CagriSema is for body weight loss in that population. Participants are randomized to CagriSema or to semaglutide, and the record describes two different CagriSema dose levels alongside a single semaglutide comparator dose. The study is expected to last about 83 weeks.

Including two dose levels of the combination in a phase 3 trial is a dose-optimization move rather than a simple confirmatory one. It suggests the sponsor is still resolving where the balance between effect and tolerability sits for the combination, and it gives regulators a basis for approving more than one strength. Enrolling participants both with and without type 2 diabetes in the same trial also allows a direct look at whether the diabetes-related blunting of weight loss seen with GLP-1 monotherapy persists with an added amylin analogue.

No results are attached to either recruiting record. Both are listed as ongoing, which means any figure circulating about how much weight CagriSema produces in these specific trials is not coming from these registry entries.

Trials that test two dose levels of the same combination are doing formal dose selection, which is related to but distinct from what titration means for an individual on an established regimen.

Where the earlier large phase 3 study stands

The program's largest registered study, NCT05567796, has a planned enrollment of 3,400 participants with excess body weight and is now listed as active but not recruiting — meaning enrollment has closed while follow-up continues. Its main phase randomizes participants across four arms: CagriSema, cagrilintide alone, semaglutide alone, and a placebo the record calls a "dummy" medicine, all given as a weekly injection.

That four-arm structure is the scientifically important part. Comparing the combination against each of its components separately, plus placebo, is what allows a sponsor to show that the combined product does more than either molecule alone rather than simply more than nothing. The record describes injections given subcutaneously in the abdomen, thigh or upper arm.

The study also carries an extension phase in which selected participants receive no study medicine, and investigators observe what happens to body weight and to weight-related conditions afterward. Off-treatment follow-up is one of the least-answered questions in this drug class, and a prospectively designed extension is a more credible source on it than retrospective analyses.

The registry records note only that study drugs may have side effects, without specifics, which is a reminder that side-effect logging against your own timeline is the only record specific to you.

The phase 1 formulation study: why 18 people matter

Also in the registry is NCT06716307, a completed phase 1 study in 18 adults with overweight or obesity. It compared blood levels of cagrilintide and semaglutide when the same dose was delivered in two different versions of injectable CagriSema, with each participant receiving both versions at different clinic visits over about 18 weeks.

Studies like this are pharmacokinetic bridging work: they establish that a reformulated or redesigned product delivers drug into the bloodstream the same way the version used in the pivotal trials did. In practice, that usually means a change in presentation — a different device, container or concentration — that the sponsor wants to carry into commercial supply without repeating a phase 3 program.

For readers who track how products actually arrive, this is the least glamorous and most practically relevant entry in the set. The version of a drug that reaches pharmacies is often not physically identical to the one used in the trials that got it approved, and bridging studies are the documented link between the two.

According to the newly recruiting pediatric trial record, 460 children and adolescents will be randomized to CagriSema, cagrilintide, semaglutide or placebo, with an extension phase extending total participation to about four years and ten months.

What is still unresolved

None of these records contains results. The registry describes what is being tested, in whom, and for how long; it does not report outcomes, and no efficacy or safety conclusion about CagriSema can be drawn from these entries. Peer-reviewed publication and regulatory review are separate steps that have not happened for the recruiting trials.

There is also no approval or availability information in any of the records. Novo Nordisk's own study descriptions state plainly that CagriSema is still being tested and is not yet available for doctors to prescribe. Anything sold as "CagriSema" or as a cagrilintide-semaglutide blend outside a clinical trial is not the studied product and has not been through the review process these trials feed into.

The timeline implied by the records stretches well past 2026: an 83-week adult trial that is still recruiting, and a pediatric study whose extension runs close to five years. The near-term news will come from the studies that have already closed enrollment.

The 2,500-participant adult study listing describes a roughly 83-week trial comparing two CagriSema dose levels against semaglutide in people with obesity, with or without type 2 diabetes. the 2,500-participant adult study listing.

What this means if you're tracking a protocol

If you are tracking a semaglutide protocol now, nothing in these registry updates changes it. What they do change is the horizon. A combination product built on semaglutide plus an amylin analogue is being tested against semaglutide alone in thousands of adults and, for the first time in this program, in adolescents. If it is eventually approved, the switch conversation with a provider will hinge on comparative data from exactly these trials — which makes a clean, continuous record of your own response on a single-agent regimen more useful, not less.

The phase 1 bridging study is the one with a concrete tracking lesson. It is a reminder that the same nominal dose can be presented in different product versions, and that what you record should include which presentation you actually have on hand, not just the drug name. People who log the product form, the concentration on the label, and the lot alongside their weekly entries are the ones who can later tell whether a change in how something felt tracked with a change in the product itself.

The four-arm design of the largest study, with an off-treatment extension, is also worth noting for anyone who has wondered what a planned pause looks like when it is studied rather than improvised. Trials like this are where evidence on post-treatment weight trajectory will come from. Until it arrives, your own logged history through any interruption is the only record specific to you.

Frequently asked questions

Is CagriSema approved or available by prescription?

No. The ClinicalTrials.gov records for Novo Nordisk's CagriSema studies state that the combination is still being tested and is not yet available for doctors to prescribe. It remains an investigational product, and the phase 3 trials now recruiting are part of the evidence base that regulators would review before any approval decision. No availability date appears in the registry entries.

How is CagriSema different from semaglutide alone?

CagriSema combines semaglutide, a GLP-1 receptor agonist, with cagrilintide, a long-acting analogue of the hormone amylin. Semaglutide acts on incretin signaling; amylin acts through a separate satiety pathway. The registered phase 3 trials are designed to test whether the combination produces more weight loss than either molecule alone or placebo, which is why several studies include cagrilintide-only and semaglutide-only arms.

What ages does the new CagriSema pediatric trial cover?

The recruiting phase 3 study NCT07253285 enrolls children and adolescents with excess body weight, with a planned enrollment of 460 participants. Participants are randomized to CagriSema, cagrilintide, semaglutide or placebo. The main study lasts about a year and six months, and participants who continue into the extension — which excludes those who received semaglutide — remain in the study for roughly four years and ten months in total.

Do these registry records report how much weight CagriSema causes people to lose?

No. ClinicalTrials.gov entries describe study design, population, enrollment and duration, not outcomes. The recruiting trials have no results posted, and the largest study is listed as active but not recruiting with follow-up ongoing. Any specific weight-loss figure attributed to these particular trials is not coming from these records and should be traced to a published paper or company disclosure.

Why does a phase 1 study with only 18 participants matter?

NCT06716307 was a pharmacokinetic bridging study: it compared blood levels of cagrilintide and semaglutide delivered from two different versions of injectable CagriSema in the same 18 participants over about 18 weeks. Small studies like this establish that a reformulated or redesigned presentation delivers drug into the bloodstream the same way the version used in pivotal trials did, without repeating a full phase 3 program.

Sources

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
ClinicalTrials.gov · August 31, 2026
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
ClinicalTrials.gov · August 31, 2026
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
ClinicalTrials.gov · August 31, 2026
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
ClinicalTrials.gov · August 31, 2026

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