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The trial is taking place at:
M

Mercury Street Medical Group, PLLC | Butte, MT

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A Study of CT-388 in Participants with Obesity or Overweight with At Least One Weight-Related Comorbidity

C

Carmot Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Overweight
Obesity

Treatments

Drug: CT-388
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06525935
XC45526 (Other Identifier)
CT-388-103

Details and patient eligibility

About

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female, 18 to 75 years of age
  • Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
  • At least one self-reported unsuccessful effort to lose body weight

Exclusion criteria

  • Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
  • Self-reported body weight change of >5 kg within 3 months before randomization
  • Any unbalanced/extreme diets within 3 months of the screening visit, or plan to be on such diets during the study
  • Current or recent participation in an organized weight reduction program
  • Current or recent use of any treatment that promotes weight loss or glucose metabolism
  • Current or recent use of treatment that may cause weight gain
  • Prior or planned surgical treatment for obesity
  • Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
  • History of chronic pancreatitis or acute pancreatitis within 6 months before screening
  • Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
  • History of major depressive disorder within 2 years of screening
  • Family or personal history of medullary thyroid carcinoma
  • Serum calcitonin ≥ 20 ng/L
  • Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

450 participants in 6 patient groups, including a placebo group

Arm 1: Placebo
Placebo Comparator group
Description:
Placebo administered subcutaneously (SC) once weekly.
Treatment:
Drug: Placebo
Arm 2: CT-388 Dose Level 1 (Low)
Experimental group
Description:
CT-388 Dose Level 1 administered SC once weekly.
Treatment:
Drug: CT-388
Arm 3: CT-388 Dose Level 2
Experimental group
Description:
CT-388 Dose Level 2 administered SC once weekly.
Treatment:
Drug: CT-388
Arm 4: CT-388 Dose Level 3
Experimental group
Description:
CT-388 Dose Level 3 administered SC once weekly.
Treatment:
Drug: CT-388
Arm 5: CT-388 Dose Level 4
Experimental group
Description:
CT-388 Dose Level 4 administered SC once weekly.
Treatment:
Drug: CT-388
Arm 6: CT-388 Dose Level 5 (High)
Experimental group
Description:
CT-388 Dose Level 5 administered SC once weekly.
Treatment:
Drug: CT-388

Trial contacts and locations

35

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Central trial contact

Reference Study ID: CT-388-103 Roche study # : XC45526

Data sourced from clinicaltrials.gov

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