A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus

Conditions

Diabetes

Brief summary

This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.

Chakravarthy MV, Rodriguez R, Hergarden A, Elliott MA, Frias JP, Argüelles-Tello FA, Tenorio E, Rankin JE, Wu J, Krishnan S, Erlanson DA, Fucini RV, Bone D, Iwig JS, Acosta L, Untereiner A, Pant A, Patton A, Sanchez-Sanchez LL, Luo J, Steinberg A, Bialonczyk D, Hansen SK.

2025-11-28

10.1016/j.molmet.2025.102291

763-P: Glycemic Control, Weight Reduction, and Safety with CT-388, a Signal-Biased Dual GLP-1/GIP Receptor Agonist—Results from a 12-Week Cohort in Adults with Obesity and Type 2 Diabetes

Arthur G. Steinberg, FEDERICO A. ARGÜELLES-TELLO, Luz María Sánchez‐Sánchez, W. Ortiz, Michael Elliott et al. (11 authors)

Diabetes2025-06-131 citations

10.2337/db25-763-p

125-OR: Effect of CT-388, a Signal-Biased Dual GLP-1/GIP Receptor Agonist, on Liver-Related MRI Parameters in Patients with Obesity

A. Steinberg, FEDERICO A. ARGÜELLES-TELLO, Jun Zhu, Jingtao Wu, HELENA B. THOMAIDES-BREARS et al. (10 authors)

Diabetes2025-06-13

10.2337/db25-125-or

Interventions

DRUGCT-388

Synthetic Peptide

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Males or females * 18-65 years old, inclusive * BMI 27.0-40.0, inclusive * Stable body weight for 2 months

Exclusion criteria

* Significant medical history * Uncontrolled hypertension * History of malignancy

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events as assessed by self-report	Baseline up to 24 weeks	Safety and tolerability

Secondary

Measure	Time frame	Description
Maximum observed drug concentration (Cmax)	Baseline up to 24 weeks	PK Cmax
Elimination half-life	Baseline up to 24 weeks	PK t1/2
Area under the concentration versus time curve (AUC)	Baseline up to 24 weeks	PK AUC
Change in mean glucose levels	Baseline up to 24 weeks	PD glucose
Change in mean insulin levels	Baseline up to 24 weeks	PD insulin
Change in mean body weight	Baseline up to 24 weeks	PD body weight

Countries

Australia, Mexico

Outcome results

None listed