DelfaGLP-1 Atlas

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CompletedPhase 2

A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus

Asset

CT-868

Subcutaneous · GLP-1 / GIP dual

Listed sites

5

Recruiting sites

—

Enrollment

103

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥27

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 IDNCT05110846
Org study IDCT-868-002
Secondary IDBP45664Roche Protocol Number

Timeline

Milestones

Study first posted2021-11-08actual
Study start2022-02-22actual
Primary completion2023-02-28actual
Study completion2023-02-28actual
Last update posted2026-02-05actual

Assets

Investigational agents

CT-868

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Males or Females with T2DM
•BMI of ≥27 kg/m2, inclusive
•18-75 years old, inclusive
•Stable body weight for 3 months

Exclusion criteria

•Significant medical history
•Uncontrolled diabetes
•History of malignancy

Endpoints (29)

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

Weight & body composition
11
Glycemic / diabetes
9
Cardiometabolic biomarkers
6
Safety / tolerability / PK
3

Weight & body composition

11 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in Body Weight at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute (kg) Change from Baseline in Body Weight at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥5% Body Weight Loss from Baseline at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥10% Body Weight Loss from Baseline at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥15% Body Weight Loss from Baseline at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥20% Body Weight Loss from Baseline at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Hip Circumference at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist-to-Hip Ratio at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist-to-Height Ratio at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI) at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

BMI, change

change from baseline, improvement

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint

Change from Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 26

Time frame:Baseline and Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in HbA1c at Week 12

Time frame:Baseline and Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <5.7% at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤6.5% at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline in Fasting Insulin at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change from Baseline in Total Cholesterol at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from Baseline in Triglycerides at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Low Density Lipoprotein (LDL) Cholesterol at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change from Baseline in High Density Lipoprotein (HDL) Cholesterol at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change from Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Apolipoprotein B at Weeks 12 and 26

Time frame:Baseline and Weeks 12 and 26

ApoB, change

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Percentage of Participants with at Least One Treatment-Emergent Adverse Event

Time frame:From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)

Treatment-emergent AEs (any)

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants with at Least One Hypoglycemic Event

Time frame:From first dose of study drug until 4 weeks after the last dose of study drug (30 weeks)

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants Testing Positive for Anti-Drug Antibodies to CT-868 at Baseline and Anytime Post-Baseline

Time frame:Baseline and Post-Baseline (up to 30 weeks)

Immunogenicity (ADA)

threshold achievement, 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.