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Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus

10. maj 2026 opdateret af: Mapi Pharma Ltd.

A Prospective, Multicenter, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an approved and well-established therapy for type 2 diabetes mellitus (T2DM), providing both robust glycemic control and weight reduction. Semaglutide Depot, is a long-acting formulation of semaglutide, designed for once every four weeks administration, intended to reduce treatment burden, and improve adherence supporting sustained glycemic control over time.

This Phase I/Ila dose escalation study design to evaluate the safety, tolerability, pharmacokinetics and efficacy of Semaglutide Depot in adults with T2DM.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study Title:

A Prospective, Multicenter, Open-Label, Dose Escalation Phase I/Ila Study to Assess the Safety, Tolerability, and Efficacy of Semaglutide Depot in Subjects with Type 2 Diabetes Mellitus

Background:

Type 2 diabetes mellitus (T2DM) is a chronic condition in which the body cannot properly use insulin, leading to elevated blood glucose levels. It is often associated with overweight or obesity and can lead to serious complications if not well controlled.

Semaglutide, is a GLP 1 receptor agonist, that helps lower blood glucose by increasing insulin secretion, reducing glucagon (a hormone that raises blood glucose), slowing gastric emptying, and reducing appetite. In addition to improving glycemic control, it also supports weight loss and has demonstrated cardiovascular benefits. Semaglutide is already approved in several formulations (examples: Ozempic® for type 2 diabetes and Wegovy® for weight management), but these require once-weekly injections.

Semaglutide Depot (SG Depot) is a new, long-acting formulation developed by Mapi Pharma Ltd. It is designed to be injected once every 4 weeks (once monthly), which may make treatment easier and improve adherence for people with diabetes.

Study Design:

  • Type: Phase I/Ila, open label, dose escalation study, prospective study
  • Sponsor: Mapi Pharma Ltd., Ness Ziona, Israel
  • Sites: Tel Aviv, Israel
  • Participants: Up to 24 adults with type 2 diabetes
  • Groups: Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg
  • Dose escalation: will be allowed only after review of safety data

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Israel
      • Tel Aviv, Israel, 6423906
        • Mapi pharma Investigational Site ISR001

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Adults aged 18-64 years with T2DM, BMI 25-35 kg/m2
  2. On stable Semaglutide 1 mg weekly and for at least 3 months
  3. HbA1c <8%, eGFR≥60 ml/minute
  4. For women: either non-childbearing potential or agreement to use acceptable contraception

Exclusion Criteria:

  1. Participation in another investigational drug clinical study within 3 months
  2. History of cardiovascular or cerebrovascular disease
  3. Neuropathy or retinopathy or macular edema necessitating medical treatment
  4. Type 1 diabetes
  5. Unstable weight (> 5% change in the last 3 months)
  6. Current use of insulin and /or sulfonylureas and/or glinides
  7. Known contraindications to Semaglutide (per FDA-approved Semaglutide label)
  8. Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years
  9. Moderate or severe hepatic impairment, (ALT or AST> 2 x upper limit of normal (ULN)
  10. Severe hypertriglyceridemia (triglycerides >500 mg/dl)
  11. Pregnant or breast feeding
  12. Any condition that may increase risk or interfere with study participation (per Investigator judgement)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1 - SG Depot 2 mg
Medicin: SG Depot 2 mg
2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
Eksperimentel: Cohort 2 - SG Depot 4 mg
Medicin: SG Depot 4 mg
4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
Eksperimentel: Cohort 3 - SG Depot 6 mg
Medicin: SG Depot 6 mg
6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
Eksperimentel: Cohort 4 - SG Depot 8 mg
Medicin: SG Depot 8 mg
8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The rate of treatment-associated adverse events (AEs)
Tidsramme: Through study completion, up to 28 weeks for each subject
Through study completion, up to 28 weeks for each subject
Plasma concentration of semaglutide
Tidsramme: Through study completion, up to 28 weeks for each subject
Through study completion, up to 28 weeks for each subject

Sekundære resultatmål

Resultatmål
Tidsramme
Change in HbA1c
Tidsramme: Baseline (week 0), week 12
Baseline (week 0), week 12
Change in fasting plasma glucose from baseline
Tidsramme: Baseline (week 0), week 12
Baseline (week 0), week 12
Change in body weight from baseline
Tidsramme: Baseline (week 0), week 12
Baseline (week 0), week 12
The maximal tolerated dose (MTD) of SG Depot
Tidsramme: Through study completion, up to 28 weeks for each subject
Through study completion, up to 28 weeks for each subject

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mapi Pharma Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

4. februar 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SG Depot-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes type 2

Kliniske forsøg med SG Depot 2 mg

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner