SCO-792 Phase 2a in Subjects with Obese Type 2 Diabetes Mellitus on Metformin Monotherapy

A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of SCO-792 in Subjects with Obese Type 2 Diabetes Mellitus on Metformin Monotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080224771

Enrollment

100

Registered

2019-07-08

Start date

2019-11-28

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

Obese Type 2 Diabetes Mellitus on Metformin Monotherapy

Interventions

investigational material(s) Generic name etc : SCO-792 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -The subject signs and dates a written, informed consent form prior to the initiation of any study procedures. -The subject is capable of understanding and complying with protocol requirements. -The subject is either male or female and aged 18 to 65 years (inclusive) at signing of informed consent. -The subject has been treated with stable doses of metformin monotherapy (>=1000 mg/day) for at least 3 months prior to Visit 1 as determined by subject report. -The subject has a HbA1c >=7.0% (>=53 mmol/mol) and =30kg/m2 as assessed by the study site at Visit 1 and Visit 2.

Exclusion criteria

Exclusion criteria: 1.The subject has a history of type 1 diabetes mellitus or a history of ketoacidosis; 2.The subject has a history of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant);

Design outcomes

Primary

Measure	Time frame
safety exploratory -Incidence and severity of adverse events (AE) -Incidence of serious adverse events -Clinically significant changes from baseline in -clinical laboratory tests -12-lead electrocardiograms -vital signs -physical examinations -Incidence and severity of hypoglycemia and hyperglycemia efficacy exploratory -Change in HbA1c value from baseline at the completion of the treatment period (Week 12).	—

Measure

Time frame

safety exploratory -Incidence and severity of adverse events (AE) -Incidence of serious adverse events -Clinically significant changes from baseline in -clinical laboratory tests -12-lead electrocardiograms -vital signs -physical examinations -Incidence and severity of hypoglycemia and hyperglycemia efficacy exploratory -Change in HbA1c value from baseline at the completion of the treatment period (Week 12).

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Secondary

Measure	Time frame
efficacy exploratory -Change in fasting plasma glucose value from baseline at the completion of the treatment period (Week 12). efficacy exploratory -Percent change in body weight value from baseline at the completion of the treatment period (Week 12).	—

Countries

Oceania

Outcome results

None listed

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