Phase 2
Completed N=499
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
Source: ClinicalTrials.gov NCT04707313 ↗Enrolled (actual)
499
Serious AEs
3.0%
Results posted
Oct 2024
Primary outcomePrimary: Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26 — 0.17; -5.43; -4.83; -8.94 Percent change — p=<.0001
Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood.
This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening).
There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26 |
0.17; -5.43; -4.83; -8.94; -6.43; -9.36 | <.0001 sig |
| PRIMARY Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32 |
1.40; -6.92; -7.15; -11.65 | <.0001 sig |
| SECONDARY Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs) |
50; 52; 59; 54; 32; 59 | — |
| SECONDARY Cohort 3: Number of Participants With TEAEs and TESAEs |
13; 30; 34; 34; 0; 2 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality |
66; 56; 60; 57; 37; 54 | — |
| SECONDARY Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality |
15; 31; 34; 32 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data |
0; 0; 1; 0; 1; 2 | — |
| SECONDARY Cohort 3: Number of Participants According to Categorization of Vital Signs Data |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Cohort 3: Number of Participants According to Categorization of ECG Parameters |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation |
0; 0; 0; 0 | — |
| SECONDARY Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation |
0; 0; 0; 0 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment |
6; 16; 15; 17; 12; 15 | — |
| SECONDARY Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment |
0; 9; 11; 10 | — |
| SECONDARY Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22 |
-0.13; -0.85; -0.54; -0.98; -0.58; -0.87 | — |
| SECONDARY Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28 |
-0.37; -1.38; -0.95; -1.02; -0.06; -2.07 | — |
| SECONDARY Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26 |
-1.25; -6.49; -5.75; -6.19; -5.98; -9.05 | — |
| SECONDARY Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32 |
0.19; -6.27; -7.77; -11.43 | — |
| SECONDARY Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26 |
-0.002; -0.002; -0.015; 0.001; -0.014; -0.015 | — |
| SECONDARY Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32 |
0.010; -0.012; -0.009; -0.016 | — |
| SECONDARY Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26 |
0.00; -0.24; -0.24; -0.26; -0.25; -0.29 | — |
| SECONDARY Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32 |
-0.05; -0.16; -0.26; -0.29; 0.05; -0.13 | — |
| SECONDARY Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26 |
3.22; -2.93; -2.56; -4.02; -2.02; -4.51 | — |
| SECONDARY Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32 |
-1.82; -0.83; 0.96; 3.84; 0.10; 1.79 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
- Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1
Exclusion Criteria
- Any condition possibly affecting drug absorption
- Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
- Any malignancy not considered cured
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
- History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis
- Symptomatic gallbladder disease
- Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
- History of major depressive disorder or other severe psychiatric disorders within the last 2 years
- Any lifetime history of a suicide attempt
- Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
- Known history of HIV
- Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
- Clinically relevant ECG abnormalities
- Positive urine drug screen
- Participation in a formal weight reduction program within 90 days prior to visit 1
Data sourced from ClinicalTrials.gov (NCT04707313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.