Safety, tolerability, PK and PD of SCO-094 in type 2 diabetic patients

Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial to investigate tolerability, safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SCO-094 subcutaneously administered in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225227

Enrollment

Registered

2020-06-11

Start date

2020-08-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

investigational material(s) Generic name etc : SCO-094 INN of investigational material : - Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetic Caucasian male or females will be included if they are aged between 18 and 65 (inclusive), with a body mass index (BMI) between 18.0 and 35.0 kg/m2. Patients must be stable and treated with either diet and exercise alone or an anti-glycaemic monotherapy (metformin, DPP-4i, pioglitazone, an SU or an SGLT-2i). Patients must agree to use effective methods of contraception.

Exclusion criteria

Exclusion criteria: Patients treated with insulin such as type 1 diabetes or evidence of C-peptide deficiency and patients with current or recurrent disease; e.g., cardiovascular, haematological, neurological, endocrine, immunological, renal, hepatic or gastrointestinal or other conditions) that could affect the action, absorption, or disposition of SCO-094, or could affect clinical assessments or clinical laboratory evaluations.

Design outcomes

Primary

Measure	Time frame
safety The safety and tolerability of SCO-094 as measured by the incidence of treatment emergent adverse events (TEAEs), proportion of patients with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation, and urinalysis), proportion of patients with morphological and/or rhythm abnormalities on electrocardiogram (ECG), proportion of patients with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals) and proportion of patients with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation and body temperature).	—

Measure

Time frame

safety The safety and tolerability of SCO-094 as measured by the incidence of treatment emergent adverse events (TEAEs), proportion of patients with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation, and urinalysis), proportion of patients with morphological and/or rhythm abnormalities on electrocardiogram (ECG), proportion of patients with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals) and proportion of patients with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation and body temperature).

—

Secondary

Measure	Time frame
pharmacokinetics PK endpoints	—

Countries

Europe

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026