UnknownPhase 3

16-week Flexible vs. 8-week Semaglutide Titration

A Randomized Controlled Open Label Pilot Study Examining the Safety of a 16 Week Flexible Titration Regimen vs. Label-recommended 8-week Semaglutide Titration Regimen

Lead sponsor

Tel-Aviv Sourasky Medical Center

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

100

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•Gastrointestinal adverse events (GI-AEs) (Nausea, Vomiting, Diarrhea)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04447859

Org study ID0631-19

Timeline

Milestones

Study start2020-02-23actual

Study first posted2020-06-25actual

Last update posted2020-06-25actual

Primary completion2022-05-10estimated

Study completion2022-09-10estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have personally signed and dated the informed consent form indicating that he/she has been informed of all pertinent aspects of the trial.

•Be willing and able to comply with the scheduled visits and other study procedures.

•Meet one of the following categories:

1. The subject is a male.

2. The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.

3. The subject is a female who is of reproductive potential and agrees to avoid becoming pregnant: while receiving study drug and for 60 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are‡:

Single method (one of the following is acceptable):

•non-hormonal intrauterine device (IUD)

•vasectomy of a female subject's male partner

Combination method (requires use of two of the following):

•diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)

•cervical cap with spermicide (nulliparous women only)

•contraceptive sponge (nulliparous women only)

•male condom or female condom (cannot be used together)

Exclusion criteria

•Has a known contraindication to use of GLP-1 agonists.

•Has been treated with a GLP-1 agonist in the last 30 days.

•Has a history of type 1 diabetes mellitus

•Has a medical history of untreated active proliferative retinopathy.

•Has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or blinded investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Gastrointestinal adverse events (GI-AEs)

Time frame:16 weeks - from visit one to visit seven (and in each visit alone)

event count, event

componentsNausea, Vomiting, Diarrhea

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.