A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03842202
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Drug: Semaglutide; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• Official Title: Effect of Semaglutide 2.4 mg Once-weekly on Gastric Emptying in Subjects With Obesity
• Actual Study Start Date: Feb 15, 2019
• Actual Primary Completion Date: Nov 4, 2019
• Actual Study Completion Date: Nov 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.	Drug: Semaglutide; Participants will receive gradually increasing doses of semaglutide (subcutaneous [s.c.], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.
Placebo Comparator: Placebo (Semaglutide) Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks	Drug: Placebo; Participants will receive once weekly injections of semaglutide matched placebo.

Outcome Measures

Primary Outcome Measures

1. AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state [0 to 5 hours after standardised meal (day 142)]

   Measured in h*micrograms/mL

Secondary Outcome Measures

1. AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state [0 to 1 hour after standardised meal (day 142)]

   Measured in h*micrograms/mL

2. Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours [0 to 5 hours after standardised meal (day 142)]

   Measured in micrograms/mL

3. Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours [0 to 5 hours after standardised meal (day 142)]

   Measured in hours

4. Energy intake during ad libitum lunch [Day 142]

   Measured in kilojoules

5. Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal [Day 142]

   Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

6. Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal [Day 142]

   Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

7. Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal [Day 142]

   Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

8. Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal [Day 142]

   Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

9. Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal [Day 142]

   Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent

• Body mass index (BMI) between 30.0 and 45.0 kg/m^2 (both inclusive)

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

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Berlin		Germany	14050

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03842202
• Other Study ID Numbers: NN9536-4455; U1111-1215-9915; 2018-002497-42
• First Posted: Feb 15, 2019
• Last Update Posted: Dec 24, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

No Results Posted as of Dec 24, 2020