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Combination Therapy

CagriSema for Obesity

Lincoln, NE

Phase 1

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged 18-64 years at the time of signing informed consent

Be between 18 and 65 years old

Must not have

Female who is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not using highly effective contraceptive method

Previous dosing with an amylin analogue

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 0 hours (pre-dose) to 1176 hours (post-dose)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare the blood levels of two medications, cagrilintide and semaglutide, when given in two different versions of a new medication called CagriSema. Participants

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Who is the study for?

This trial is for adults with overweight or obesity. Participants will receive injections of two different versions of a medication called CagriSema, which combines cagrilintide and semaglutide, at separate times. The study aims to compare the blood levels of these medications after injection.Check my eligibility

What is being tested?

The trial is testing two versions of CagriSema (labeled as 'CagriSema A' and 'Cagrilintide B with Semaglutide I') to see how they affect blood levels of cagrilintide and semaglutide in participants. It's designed to determine if there are differences between the two formulations.See study design

What are the potential side effects?

As with any medicine, potential side effects may occur from CagriSema injections. While specific side effects aren't listed here, common ones associated with injectable medications for weight management can include nausea, digestive issues, headache, fatigue, and reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

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I have been treated with an amylin analogue before.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 0 hours (pre-dose) to 1176 hours (post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 0 hours (pre-dose) to 1176 hours (post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 hours (pre-dose) to 1176 hours (post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector

AUC0-∞,sema,0.25mg/0.25mg,SD: Area under the semaglutide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector

Cmax,cagri,0.25mg/0.25mg,SD: Maximum concentration of cagrilintide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector

+1 more

Secondary study objectives

Number of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment sequence 2Experimental Treatment2 Interventions

Participants will receive a single s.c. dose of CagriSema A in PDS290 pen-injector in period 1 followed by a single s.c. dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 2 separated by a wash out period of minimum 7 weeks.

Group II: Treatment sequence 1Experimental Treatment2 Interventions

Participants will receive a single subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 1 followed by a single s.c. dose of CagriSema A in PDS290 pen-injector in period 2 separated by a wash out period of minimum 7 weeks.

0 / 3Eligibility criteria met