16-week Flexible vs. 8-week Semaglutide Titration

NCT04447859 · Unknown status

Last updated 2026-05-28

This clinical trial compares the side effects of two different ways of increasing the dose of semaglutide in adults with type 2 diabetes over 16 weeks.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 100 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2020-02 · est. completion 2022-09

Where 1 site · Israel

What this study is testing ClinicalTrials.gov NCT04447859 ↗

Description as written by the study sponsor.

Semaglutide is a Glucagon Like Peptide 1 (GLP-1) receptor agonist recently approved in Israel to improve glycemic control in patients with type 2 diabetes mellitus. Semaglutide is currently administered as a weekly subcutaneous injection.Treatment with semaglutide is associated with the occurrence of gastrointestinal adverse events (GI-AEs) commonly observed during GLP-1 receptor agonist treatment. The most common adverse reactions, reported in ≥5% of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and constipation. In this trial we plan to explore the effect of a slower titration regimen of semaglutide vs. the current label-recommended dose escalation regimen on the occurrence of GI-AEs.

Treatments tested

Semaglutide also known as Ozempic Drug

Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
label recommended titration Other

label recommended titration

Main thing measured	Gastrointestinal adverse events (GI-AEs)
Sponsor	Tel-Aviv Sourasky Medical Center
Conditions studied	Diabetes type2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04447859 ↗