Obesity, Overweight
Conditions
Brief summary
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.
Interventions
DRUGPlacebo
Placebo will be volume- matched and administered subcutaneously (SC) once weekly.
DRUGEnicepatide
Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Sponsors
Carmot Therapeutics, Inc.
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Body Weight from Baseline to Week 48 | Baseline to Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 | Baseline and Week 48 |
| Absolute Change in Body Weight (kg) from Baseline to Week 48 | Baseline to Week 48 |
| Percent Change in Body Weight from Baseline to Week 48 by Obesity Class | Baseline to Week 48 |
| Change in Body Mass Index (BMI) from Baseline to Week 48 | Baseline to Week 48 |
| Change in Waist Circumference from Baseline to Week 48 | Baseline to Week 48 |
| Change in Hip Circumference from Baseline to Week 48 | Baseline to Week 48 |
| Change in Waist-to-Hip Ratio from Baseline to Week 48 | Baseline to Week 48 |
| Change in Waist-to-Height Ratio from Baseline to Week 48 | Baseline to Week 48 |
| Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting Plasma Glucose from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting Insulin from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting C-peptide from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48 | Baseline to Week 48 |
| Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48 | Baseline to Week 48 |
| Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c | Baseline and Week 48 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trials
Carmot Therapeutics, Inc., a Member of the Roche Group
Outcome results
None listed