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Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.
Study details:
A multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-05-09
Primary completion: 2024-11-01
Study completion finish: 2024-11-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05814107
Intervention or treatment
DRUG: CT-996
DRUG: Placebo
Conditions
- • Type 2 Diabetes
- • Overweight or Obesity
Find a site
Closest Location:
Carmot Clinical Research Unit 101
Research sites nearby
Select from list below to view details:
Carmot Clinical Research Unit 101
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: CT-996
| DRUG: CT-996
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events in CT-996 participants | To evaluate the safety and tolerability of CT-996 | Baseline up to 28 days |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Maximum observe drug concentration (Cmax) of CT-996 | PK Cmax | Baseline up to 28 days |
| Effect of a High-Fat Meal on Plasma Concentration of CT-996 | Determine the effect of a high-fat meal on the PK of CT-996 following a single dose | Baseline up to 14 days |
Frequently Asked Questions
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