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

NCT03842202 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN9536-4455U1111-1215-99152018-002497-42
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state

  Measured in h\*micrograms/mL

  0 to 5 hours after standardised meal (day 142)

Secondary Outcomes (9)

• 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)

• Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours

  0 to 5 hours after standardised meal (day 142)

• Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours

  0 to 5 hours after standardised meal (day 142)

• Energy intake during ad libitum lunch

  Day 142

• 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

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Placebo (Semaglutide)

PLACEBO COMPARATOR

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

Interventions

Semaglutide DRUG

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.

Semaglutide

Placebo DRUG

Participants will receive once weekly injections of semaglutide matched placebo.

Placebo (Semaglutide)

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 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)

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3.

  PMID: 33269530 RESULT

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: February 15, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)