A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose

A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess Pharmacokinetic and Pharmacodynamic Effects of CT-868 on the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04973111

Enrollment

Registered

2021-07-22

Start date

2021-07-16

Completion date

2022-04-22

Last updated

2025-03-28

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

Conditions

Diabetes

Keywords

Diabetes Mellitus, Diabetes Mellitus, Type 2, Overweight, Metabolic Diseases, Body Weight

Brief summary

A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.

Interventions

DRUGCT-868 as SC Injection

CT-868

DRUGPlacebo as SC Injection

Placebo

DRUGActive Comparator as SC Injection

Active Comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Part 1: Obese Otherwise Healthy Males * Part 2: Males or Females with T2D * Part 1: BMI 30.0-35.0, inclusive * Part 2: BMI 27.0-45.0, inclusive * 18-65 years old, inclusive * Stable body weight for 2 months

Exclusion criteria

* Significant medical history * Uncontrolled hypertension * History of malignancy

Design outcomes

Primary

Measure	Time frame
Change in insulin secretion rate and ambient glucose levels	Baseline up to 4 days

Secondary

Measure	Time frame
Change in blood insulin levels at each level of glucose infusion	Baseline up to 4 days
Change in blood glucose levels at each level of glucose infusion	Baseline up to 4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026