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

ConditionDiabete Type 2
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorMapi Pharma Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-64 years with T2DM, BMI 25-35 kg/m2

On stable Semaglutide 1 mg weekly and for at least 3 months

HbA1c <8%, eGFR≥60 ml/minute

For women: either non-childbearing potential or agreement to use acceptable contraception

Disqualifiers

Participation in another investigational drug clinical study within 3 months

History of cardiovascular or cerebrovascular disease

Neuropathy or retinopathy or macular edema necessitating medical treatment

Type 1 diabetes

Trial design

Design model

Sequential

Treatments tested in this trial

  • SG Depot 2 mg

    Drug

    2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

  • SG Depot 4 mg

    Drug

    4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

  • SG Depot 6 mg

    Drug

    6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

  • SG Depot 8 mg

    Drug

    8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Cohort 1 - SG Depot 2 mgExperimental treatment 1 intervention
Group B: Cohort 2 - SG Depot 4 mgExperimental treatment 1 intervention
Group C: Cohort 3 - SG Depot 6 mgExperimental treatment 1 intervention
Group D: Cohort 4 - SG Depot 8 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rate of treatment-associated adverse events (AEs)

Time frame
Through study completion, up to 28 weeks for each subject
2

Plasma concentration of semaglutide

Time frame
Through study completion, up to 28 weeks for each subject

Secondary outcomes

1

Change in HbA1c

Time frame
Baseline (week 0), week 12
2

Change in fasting plasma glucose from baseline

Time frame
Baseline (week 0), week 12
3

Change in body weight from baseline

Time frame
Baseline (week 0), week 12
4

The maximal tolerated dose (MTD) of SG Depot

Time frame
Through study completion, up to 28 weeks for each subject

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mapi Pharma Ltd.

Lead sponsor

Source ClinicalTrials.gov
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