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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg

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
Cagrilintide and semaglutide
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,419,696 Total Patients Enrolled
144 Trials studying Obesity
132,446 Patients Enrolled for Obesity
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
45,115 Total Patients Enrolled
10 Trials studying Obesity
18,338 Patients Enrolled for Obesity
~10 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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