pharma · Obesity · Type 2 diabetes
NovoThirteen is a pharma organization headquartered in Bagsværd, JP. Primary therapeutic focus areas include Obesity, Type 2 diabetes, Type 2 Diabetes, Mild cognitive impairment (MCI) or mild dementia, both of the Alzhei
Phase 3 · small molecule · Obesity
CagriSema (cagrilintide + semaglutide) is a fixed-dose combination therapy in Phase 3 development by NovoThirteen for obesity management. The program combines cagrilintide, a novel acylated amylin analog, with semaglutide, an established GLP-1 receptor agonist already approved globally for weight management. The curren
Internal code NN9838-7859
CagriSema (cagrilintide + semaglutide) is a fixed-dose combination therapy in Phase 3 development by NovoThirteen for obesity management. The program combines cagrilintide, a novel acylated amylin analog, with semaglutide, an established GLP-1 receptor agonist already approved globally for weight management. The current Phase 3 trial evaluates long-term efficacy and safety of the 2.4 mg/2.4 mg once-weekly subcutaneous formulation versus placebo in participants with obesity. Semaglutide (OZEMPIC) is approved across multiple jurisdictions including Australia, the European Union, Japan, and the United States, with established regulatory pathways and clinical evidence supporting its use in metabolic disease. The combination approach represents a dual-mechanism strategy targeting complementary pathways in weight regulation. Key regulatory milestones and trial outcomes remain to be disclosed. The competitive landscape includes multiple approved anti-obesity agents and metabolic disease therapies, positioning CagriSema within an expanding therapeutic category.
Obesity represents a significant unmet medical need with limited pharmacological treatment options despite high disease prevalence and associated comorbidities. The dual-mechanism approach of CagriSema targets both amylin and GLP-1 signaling pathways, potentially offering enhanced efficacy compared to monotherapy. Semaglutide has demonstrated substantial weight loss benefits in clinical practice, and combination therapy with a complementary mechanism may provide incremental clinical advantage. The obesity treatment market is experiencing rapid expansion driven by increased disease awareness, improved reimbursement, and clinical evidence supporting pharmacological intervention. CagriSema's positioning as a fixed-dose combination simplifies dosing and may improve patient adherence compared to separate injections. The competitive landscape includes established therapies such as SAXENDA (liraglutide) and emerging agents, creating both opportunities and challenges for market penetration. Regulatory approval would expand treatment options for patients with obesity, particularly those requiring enhanced weight loss efficacy or experiencing inadequate response to monotherapy. Commercial significance is substantial given the large addressable patient population and growing acceptance of injectable anti-obesity medications in clinical practice.
Drug Class: Fixed-dose combination of amylin analog and GLP-1 receptor agonist.
Modality: Small molecule (as classified in program data).
Route of Administration: Subcutaneous injection, once weekly.
Components:
Formulation: Fixed-dose combination 2.4 mg/2.4 mg administered once weekly by subcutaneous injection.
Semaglutide Regulatory Status: Approved in Australia (PBS-listed since 2020), European Union (multiple EMA product numbers), Japan (approved March 2023), and United States (multiple NDA approvals). Related approved formulations include RYBELSUS (oral semaglutide) and other GLP-1 receptor agonists.
Patent Status: Not yet disclosed.
Also known as: obesity, obesity disease
A disorder involving an excessive amount of body fat.
ClinicalTrials.gov lists 50 registered studies for Obesity (Disorder) (AACT aggregate).
Phase breakdown: NA (46), PHASE4 (3), PHASE3 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0011122), Orphanet — obesity disorder, NCT03412149, NCT06787001, NCT06852391, NCT06881485, NCT06911918, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 3 long-term efficacy and safety trial
Ongoing Phase 3 evaluation of CagriSema 2.4 mg/2.4 mg once weekly versus placebo in participants with obesity.
The obesity treatment market includes multiple approved pharmacological options. SAXENDA (liraglutide, Teva Pharma GmbH) is an established GLP-1 receptor agonist approved for weight management. FORXIGA (dapagliflozin, AstraZeneca) and INVOKANA (canagliflozin, Teva Pharma GmbH) represent SGLT2 inhibitor class therapies with metabolic benefits. ONGLYZA (saxagliptin, AstraZeneca), TRAJENTA (linagliptin, Boehringer Ingelheim), NESINA (alogliptin, Lacuna Pharma), and VIPIDIA (vildagliptin, Takeda) are DPP-4 inhibitors with modest weight effects. ACTOS (pioglitazone, Alphapharm) and REPAGLINIDE SUN (Teva Pharma GmbH) represent older therapeutic classes. ZYNQUISTA (canagliflozin/metformin, Lexicon Pharmaceuticals) is a combination therapy. CagriSema's dual-mechanism approach differentiates it from monotherapy agents, potentially offering enhanced efficacy. The competitive positioning emphasizes combination therapy benefits and complementary pathway targeting. Semaglutide's established clinical evidence and regulatory approvals provide a strong foundation for the combination program. Market competition remains intense with multiple approved options and ongoing development of novel agents in the obesity and metabolic disease space.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| ONGLYZA | AstraZeneca | — | approved |
| ACTOS | Alphapharm Pty Ltd | — | approved |
| REPAGLINIDE SUN | Teva Pharma GmbH | — | approved |
| VIPIDIA | Takeda | — | approved |
| TRAJENTA | Boehringer Ingelheim Pty Ltd | — | approved |
| NESINA | Lacuna Pharma Pty Ltd | — | approved |
| ZYNQUISTA | LEXICON PHARMACEUTICALS, INC. | — | approved |
| SAXENDA | Teva Pharma GmbH | — | approved |
| FORXIGA | AstraZeneca | — | approved |
| QTRILMET | Takeda | — | approved |
| TRAZEC | Teva Pharma GmbH | — | approved |
| INVOKANA | Teva Pharma GmbH | — | approved |
| SIBUTRAMINE | — | Monoamine transporter inhibitor | Approved |
| SETMELANOTIDE ACETATE | — | Melanocortin receptor 4 agonist | Approved |
| SETMELANOTIDE | — | Melanocortin receptor 4 agonist | Approved |
| RIMONABANT | — | Cannabinoid CB1 receptor antagonist | Approved |
| PHENTERMINE HYDROCHLORIDE | — | Norepinephrine transporter releasing agent | Approved |
| PHENTERMINE | — | Norepinephrine transporter releasing agent | Approved |
| PHENDIMETRAZINE TARTRATE | — | Norepinephrine transporter inhibitor | Approved |
| ORLISTAT | — | Pancreatic lipase inhibitor | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Semaglutide (OZEMPIC) Regulatory Status:
CagriSema (Combination Program): Regulatory status for the fixed-dose combination not yet disclosed. Phase 3 development ongoing. Expected approval timelines and regulatory pathways remain to be announced.
CagriSema is a fixed-dose combination therapy in Phase 3 development for the treatment of obesity, combining cagrilintide (an amylin analog) with semaglutide (a GLP-1 receptor agonist).
No, CagriSema is not yet approved. The program is in Phase 3 clinical development. Semaglutide, one component of the combination, is FDA-approved for weight management.
CagriSema is being developed by NovoThirteen. Semaglutide (OZEMPIC) is manufactured by Novo Nordisk Inc and other sponsors listed in regulatory databases.
CagriSema combines two mechanisms: cagrilintide acts as an amylin analog, and semaglutide is a GLP-1 receptor agonist. Both pathways contribute to appetite regulation and weight loss, though specific mechanisms of action are not yet fully disclosed.
CagriSema is administered as a subcutaneous injection once weekly at a dose of 2.4 mg/2.4 mg.
A Phase 3 trial (NCT 2024-512144-39-00) is evaluating long-term efficacy and safety of CagriSema 2.4 mg/2.4 mg versus placebo in participants with obesity. Results have not yet been reported.
Yes, semaglutide is approved in multiple jurisdictions including Australia (PBS-listed since 2020), the European Union, Japan (March 2023), and the United States. It is marketed as OZEMPIC for weight management and other indications.
Competitors include SAXENDA (liraglutide), semaglutide monotherapy, FORXIGA (dapagliflozin), INVOKANA (canagliflozin), and various DPP-4 inhibitors such as TRAJENTA and NESINA. Multiple approved and investigational obesity therapies compete in this market.
CagriSema is in Phase 3 clinical development. The program has not yet been submitted for regulatory approval.
Expected approval timelines are not yet disclosed. Phase 3 trial completion and regulatory submission dates remain to be announced.
Cagrilintide is an acylated amylin analog. Its specific mechanism of action in weight regulation is not yet fully disclosed in available data.
No, CagriSema is not yet approved in the European Union. Semaglutide (OZEMPIC) is approved in the EU with multiple EMA product numbers and marketing authorization held by Novo Nordisk A/S.
The indication is obesity. The Phase 3 trial evaluates efficacy and safety in participants with obesity, though specific BMI or other eligibility criteria are not yet disclosed.
No partner or license agreement is disclosed in available data. CagriSema is being developed by NovoThirteen.
The internal program code is NN9838-7859.
Patent status and exclusivity information for CagriSema are not yet disclosed.
NN9838-7859 → Drug → Target → Indication → Company → Trials → Competitors
Strategic Positioning: CagriSema represents NovoThirteen's entry into the obesity treatment market via a dual-mechanism combination approach. Leveraging semaglutide's established efficacy and regulatory approvals provides a de-risked foundation for the program. The combination strategy targets complementary pathways (amylin and GLP-1 signaling), potentially offering differentiated clinical benefits.
Competitive Implications: The fixed-dose combination format simplifies patient dosing compared to separate injections, potentially improving adherence and market appeal. However, the program faces competition from established GLP-1 monotherapies (SAXENDA, semaglutide monotherapy) and emerging dual-mechanism agents. Regulatory approval would require demonstration of clinically meaningful incremental benefit over existing therapies.
Development Catalysts: Phase 3 trial completion and efficacy/safety data disclosure represent critical near-term milestones. Regulatory submissions and approval decisions across major markets (FDA, EMA, PMDA) will determine commercial viability. Patent landscape and exclusivity periods for the combination formulation remain undisclosed.
Future Milestones: Expected Phase 3 completion date, regulatory submission timelines, and approval decisions are not yet disclosed. Post-approval label expansion, additional indication development, and real-world evidence generation may follow regulatory approval.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.