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GLP-1 Receptor Agonist

Cagrilintide and semaglutide for Obesity

Phase 1

Waitlist Available

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 148 (pre-dose) to day 186 (912 hours post-dose)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two weight-loss drugs, cagrilintide and semaglutide, given either as one combined shot or as two separate shots. The study targets overweight or obese individuals to find the best way to administer these medications. These drugs work by reducing appetite and controlling blood sugar levels, which helps with weight loss. Cagrilintide is a long-acting drug currently being tested for obesity, and semaglutide has shown significant weight loss effects.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 148 (pre-dose) to day 186 (912 hours post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 148 (pre-dose) to day 186 (912 hours post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 148 (pre-dose) to day 186 (912 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

AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg

AUC0-168h,sema,2.4/2.4mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg

Cmax,cagri,2.4/2.4mg,SS maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg

+1 more

Secondary study objectives

AUC0-168h,cagri,1.7/1.7mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of cagrilintide 1.7 mg in combination with semaglutide 1.7 mg

AUC0-168h,sema,1.7/1.7mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of semaglutide 1.7 mg in combination with cagrilintide 1.7 mg

PART A: Number of treatment emergent adverse events

+5 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: Cagrilintide and semaglutide combined in DV3384 deviceExperimental Treatment1 Intervention

Participants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period.

Group II: Part A: Cagrilintide and semaglutide in separate syringesExperimental Treatment2 Interventions

Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period.

Group III: Part A: Cagrilintide and semaglutide combined in DV3384 deviceExperimental Treatment1 Intervention

Participants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cagrilintide

2023

Completed Phase 1

~150

semaglutide

2012

Completed Phase 3

~4890