A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

Phase 1

Terminated

• Conditions: Overweight; Obesity
• Interventions: Drug: Semaglutide (administered by DV3396 pen); Drug: Semaglutide (administered by PDS290 pen)

• Registration Number: NCT04012255
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-09
• Study Start: 2019-07-15
• Primary Completion: 2019-08-30
• Status Verified: 2019-10
• Study Completion: 2019-10-22
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
• Body weight between 70.0 and 130.0 kg (both inclusive)

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Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
• Inability or unwillingness to perform self-injection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DV3396	Semaglutide (administered by DV3396 pen)	Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)
PDS290	Semaglutide (administered by PDS290 pen)	Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)

Primary Outcome Measures

Name	Time	Method
AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg	0-168 hours (Day 141-148) after last 2.4 mg dose	h\*nmol/L
Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg	0-168 hours (Day 141-148) after last 2.4 mg dose	nmol/L

Secondary Outcome Measures

Name	Time	Method
Tmax,2.4mg,SS: Time of maximum observed semaglutide concentration after last 2.4 mg dose	0-168 hours (Day 141-148) after last 2.4 mg dose	h
Vss/F1mg: Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose	0-168 hours (Day 78-85) after last 1 mg dose	L
AUC0-168h,1mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 1 mg	0-168 hours (Day 78-85) after last 1 mg dose	h\*nmol/L
Tmax,1mg,SS: Time of maximum observed semaglutide concentration after last 1 mg dose	0-168 hours (Day 78-85) after last 1 mg dose	h
Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg	0-168 hours (Day 78-85) after last 1 mg dose	nmol/L
t½: Terminal elimination half-life of semaglutide after last 2.4 mg dose	0-1176 hours (Day 141-190) after last 2.4 mg dose	h
Cl/F2.4mg: Total apparent clearance of semaglutide after last 2.4 mg dose	0-168 hours (Day 141-148) after last 2.4 mg dose	L/h
Cl/F1mg: Total apparent clearance of semaglutide after last 1 mg dose	0-168 hours (Day 78-85) after last 1 mg dose	L/h
Vss/F2.4mg: Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose	0-168 hours (Day 141-148) after last 2.4 mg dose	L
Change in body weight	From baseline (Day 1, pre-dose) until the end of treatment (Day 148)	percent

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany