A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

NCT04187300 | Completed Phase 1

• 3 other identifiers: NN9536-4590U1111-1236-76972019-002909-21
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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, but it has been approved as a treatment for diabetes mellitus. 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 belly using 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 the medicine. Participants will take an injection once a week and will get a total of 21 injections 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve

  h\*nmol/L

  0-168 hours (Day 141-148) after last 2.4 mg dose

• Cmax,2.4mg,SS, Maximum observed semaglutide concentration

  nmol/L

  0-168 hours (Day 141-148) after last 2.4 mg dose

Secondary Outcomes (10)

• AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve

  0-168 hours (Day 78-85) after last 1 mg dose

• Cmax,1mg,SS, Maximum observed semaglutide concentration

  0-168 hours (Day 78-85) after last 1 mg dose

• 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

• 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

• 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

Study Arms (2)

DV3396

EXPERIMENTAL

Semaglutide administered with the DV3396 pen-injector (Formulation D)

Drug: Semaglutide

PDS290

EXPERIMENTAL

Semaglutide administered with the PDS290 pen-injector (Formulation B)

Drug: Semaglutide

Interventions

Semaglutide DRUG

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

DV3396; PDS290

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: December 16, 2019
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)