DelfaGLP-1 Atlas

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CompletedPhase 2

A Study of CT-868 in Type 1 Diabetes Mellitus

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus

Asset

CT-868

Subcutaneous · GLP-1 / GIP dual

Listed sites

22

Recruiting sites

—

Enrollment

111

actual

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06062069
Org study IDCT-868-004

Timeline

Milestones

Study first posted2023-10-02actual
Study start2023-10-19actual
Primary completion2025-07-09actual
Study completion2025-07-09actual
Last update posted2025-07-17actual

Assets

Investigational agents

CT-868

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, 18 years of age or older at the time of signing informed consent
•Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
•Body mass index greater than or equal to27.0 kg/m2
•Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit

Exclusion criteria

•Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
•Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
•Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.

Time frame:at Day 1 to Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline

Time frame:at Day 1 to Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline

Time frame:at Day 1 to Weeks 4, 8, and 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

To assess the percentage of participants achieving HbA1c of <7.0%.

Time frame:at Week 16

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

To assess the percentage of participants achieving HbA1c of ≤6.5%.

Time frame:at Week 16

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

To assess the percentage of participants achieving HbA1c of <5.7%.

Time frame:at Week 16

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change in insulin doses from baseline when comparing CT-868 to placebo.

Time frame:at Day 1 to Weeks 8 and 16

change from baseline, improvement

Other/protocol endpoint

Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.

Time frame:at Day 1 to Week 16

CGM time-in-range

descriptive, improvement

Other/protocol endpoint

Time in hyperglycemia as per CGM metrics.

Time frame:at Day 1 to Week 16

CGM time-above-range

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Time in hypoglycemia as per CGM metrics.

Time frame:at Day 1 to Week 16

CGM time-below-range

descriptive, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.