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

NCT04012255 | Terminated Phase 1

• 3 other identifiers: NN9536-4475U1111-1221-96442018-003923-13
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg

  h\*nmol/L

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

• Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg

  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 following the last administration of semaglutide s.c. 1 mg

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

• 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

• 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

Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product)

Drug: Semaglutide (administered by DV3396 pen)

PDS290

ACTIVE COMPARATOR

Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product)

Drug: Semaglutide (administered by PDS290 pen)

Interventions

Semaglutide (administered by DV3396 pen) DRUG

Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks

DV3396

Semaglutide (administered by PDS290 pen) DRUG

Increasing doses of semaglutide given sc in the stomach for 21 weeks

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 (2)

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Location

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: July 5, 2019
• First Posted: July 9, 2019
• Study Start: July 15, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 22, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)