Actively Recruiting
Evaluating the Safety and Efficacy of PF-08653944 in Adults With Overweight or Obesity and Type 2 Diabetes: A Phase 3 Randomized Placebo-Controlled Trial
Led by Pfizer · Updated on 2026-05-18
999
Participants Needed
183
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the safety and effects of a study medicine called PF-08653944 in adults who are overweight or obese and have type 2 diabetes. Type 2 diabetes is a condition where there is too much sugar in the blood, and being overweight means carrying excess body weight. The study is a phase 3, randomized, placebo-controlled trial sponsored by Pfizer to evaluate this medicine's impact on weight loss and diabetes management. Participants will receive the study medicine or a placebo via a shot under the skin in the belly area once every week. About 660 out of 1000 participants will get the study medicine while about 330 out of 1000 will receive a placebo, which looks like the medicine but contains no active drug. The study will last about 21 months and involve approximately 14 in-person visits and 5 phone visits. During the study, participants will be trained to self-inject the medicine at home. Researchers will monitor changes in body weight, blood sugar control (HbA1c), waist size, blood pressure, cholesterol levels, and quality of life through various tests and questionnaires at baseline and weeks 64 and 84. Safety will be tracked by recording any side effects or lab abnormalities. The main outcome is the percentage change in body weight from the start of the study to week 64.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or female adults aged 18 years or older
- Body mass index (BMI) of 27.0 kg/m2 or higher at screening
- Diagnosed with type 2 diabetes for at least 6 months before screening
- HbA1c between 6.5% and 10.0% at screening with stable therapy for at least 90 days
- Type 2 diabetes may be treated with diet and exercise alone or with oral antidiabetic drugs except DPP-4 inhibitors
- Not currently on GLP-1 agonists or insulin
- Motivated and willing to self-inject study medication or be assisted by a caregiver
- Willing to perform finger-stick glucose monitoring as required
- History of at least one unsuccessful attempt to lose weight through diet
You will not qualify if you...
- Female who is pregnant or breastfeeding
- Unwilling or unable to follow contraceptive requirements
- Diagnosis of type 1 diabetes or other diabetes types except type 2 diabetes
- Severe hypoglycemia or hypoglycemia unawareness within 6 months before screening
- Poorly controlled hypertension
- Prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if done more than 1 year before screening)
- Use of medications intended for weight loss within 3 months prior to randomization
- Use of chronic systemic glucocorticoid therapy for more than 2 weeks within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 64 weeks
Participants receive study medicine or placebo by subcutaneous injection to evaluate its safety and efficacy in managing overweight or obesity with type 2 diabetes.
Regular visits throughout treatment period
Duration - Up to 20 weeks after treatment
Participants are monitored for safety and efficacy outcomes after completing the treatment period.
Visits at Week 64 and Week 84
Trial Site Locations
Total: 183 locations
1
CenExel Anaheim Clinical Trials
Anaheim, California, United States, 92801
Actively Recruiting
2
Alliance Research Institute
Canoga Park, California, United States, 91304
Actively Recruiting
3
Core Healthcare Group
Cerritos, California, United States, 90703
Actively Recruiting
4
CenExel CNS - Collaborative Neuroscience Research
Los Alamitos, California, United States, 90720
Actively Recruiting
5
Cure Clinical Research
Orange, California, United States, 92866
Actively Recruiting
6
CenExel CIT
Riverside, California, United States, 92506
Actively Recruiting
7
CenExel Denver CO (Rocky Mountain Clinical Research)
Englewood, Colorado, United States, 80113
Actively Recruiting
8
Miami Eye Institute
Hollywood, Florida, United States, 33024
Actively Recruiting
9
Research Centers of America
Hollywood, Florida, United States, 33024
Actively Recruiting
10
Future Medical Research (Civia Health)
Longwood, Florida, United States, 32750
Actively Recruiting
11
Advanced Clinical Research
Miami, Florida, United States, 33156
Actively Recruiting
12
Oviedo Medical Research
Oviedo, Florida, United States, 32765
Actively Recruiting
13
CenExel FCR - ForCare Clinical Research
Tampa, Florida, United States, 33613
Actively Recruiting
14
DelRicht Research
Atlanta, Georgia, United States, 30329
Actively Recruiting
15
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
16
CenExel iResearch, LLC
Savannah, Georgia, United States, 31405
Actively Recruiting
17
Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland, United States, 21093
Actively Recruiting
18
Civia Health St. Louis
Creve Coeur, Missouri, United States, 63141
Not Yet Recruiting
19
Civia Health Independence
Independence, Missouri, United States, 64055
Not Yet Recruiting
20
DelRicht Research @ Command Family Medicine
Springfield, Missouri, United States, 65807
Actively Recruiting
21
Quality Clinical Research Inc
Omaha, Nebraska, United States, 68114
Actively Recruiting
22
Primary Care Research (Civia Health)
Papillion, Nebraska, United States, 68046
Actively Recruiting
23
CenExel HRI - Hassman Research Institute
Marlton, New Jersey, United States, 08053
Actively Recruiting
24
Forum Health_Cary (Civia)
Cary, North Carolina, United States, 27511
Actively Recruiting
25
Eximia EquiHealth Research
Durham, North Carolina, United States, 27704
Actively Recruiting
26
Eximia Research - NC, LLC
Raleigh, North Carolina, United States, 27607
Actively Recruiting
27
Civia Health Goodlettsville
Goodlettsville, Tennessee, United States, 37072
Not Yet Recruiting
28
Civia Health Nashville
La Vergne, Tennessee, United States, 37086
Not Yet Recruiting
29
Civia Health Memphis
Memphis, Tennessee, United States, 38117
Not Yet Recruiting
30
Forum Austin (Civia Health)
Austin, Texas, United States, 78578
Actively Recruiting
31
GLRI El Paso Research
El Paso, Texas, United States, 79936
Actively Recruiting
32
Dallas Clinical Research Center (Pillar Clinical Research)
Richardson, Texas, United States, 75080
Actively Recruiting
33
Pantheon Clinical Research
Bountiful, Utah, United States, 84010
Actively Recruiting
34
CenExel Salt Lake City UT (JBR Clinical Research)
Salt Lake City, Utah, United States, 84107
Actively Recruiting
35
Murray Vision Center PC
Salt Lake City, Utah, United States, 84107
Actively Recruiting
36
CINME
Buenos Aires, Argentina, C1056ABI
Not Yet Recruiting
37
CEDIC
Buenos Aires, Argentina, C1060
Not Yet Recruiting
38
Centro Medico Viamonte
Buenos Aires, Argentina, C1120AAC
Not Yet Recruiting
39
Centro Diabetologico Dr Waitman
Córdoba, Argentina, 5000
Not Yet Recruiting
40
Clinica Privada Velez Sarsfield
Córdoba, Argentina, 5000
Not Yet Recruiting
41
Instituto de Investigaciones Clinicas Cordoba
Córdoba, Argentina, X5000AAW
Not Yet Recruiting
42
CIDIM
Córdoba, Argentina, X5000AVE
Not Yet Recruiting
43
CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes
Godoy Cruz, Argentina, M5501ARP
Not Yet Recruiting
44
IIC Mar del Plata
Mar del Plata, Argentina, 7600
Not Yet Recruiting
45
CIAD Moron
Morón, Argentina, B1708EPE
Not Yet Recruiting
46
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina, T4000AXA
Not Yet Recruiting
47
Instituto Medico Catamarca (IMEC)
Santa Fe, Argentina, S2000
Not Yet Recruiting
48
MHAT Botevgrad
Botevgrad, Bulgaria, 2140
Not Yet Recruiting
49
4 Life EOOD
Burgas, Bulgaria, 8018
Not Yet Recruiting
50
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
Dobrich, Bulgaria, 9300
Not Yet Recruiting
51
Medical Center New Polyclinic Gabrovo Ltd.
Gabrovo, Bulgaria, 5300
Not Yet Recruiting
52
Medical Center Zdrave 1
Kozloduy, Bulgaria, 3320
Not Yet Recruiting
53
FutureMeds Plovdiv
Plovdiv, Bulgaria, 4000
Not Yet Recruiting
54
MHAT Sveta Karidad EAD
Plovdiv, Bulgaria, 4004
Not Yet Recruiting
55
Diagnostic Consultative Center Aleksandrovska
Sofia, Bulgaria, 1431
Not Yet Recruiting
56
Medical Center Hera EOOD
Sofia, Bulgaria, 1710
Not Yet Recruiting
57
Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
Stara Zagora, Bulgaria, 6000
Not Yet Recruiting
58
UMHAT "Prof. Dr. Stoyan Kirkovich"AD
Stara Zagora, Bulgaria, 6003
Not Yet Recruiting
59
Medical Center - Clinic Nova EOOD
Varna, Bulgaria, 9020
Not Yet Recruiting
60
Medical Centre Pratia Clinic EOOD
Varna, Bulgaria, 9020
Not Yet Recruiting
61
MC Nevromedics Ltd.
Veliko Tarnovo, Bulgaria, 5005
Not Yet Recruiting
62
Medical Center Berbatov
Yambol, Bulgaria, 8600
Not Yet Recruiting
63
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, Canada, M9R 4E1
Actively Recruiting
64
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, Canada, L8L 5G8
Actively Recruiting
65
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
66
Centricity Research Mirabel Multispecialty (Centricity Research)
Mirabel, Quebec, Canada, J7J 2K8
Actively Recruiting
67
Diacentrum Brandys n.L.
Brandys Nad Lebem, Czechia, 25001
Not Yet Recruiting
68
Nemocnice Jihlava
Jihlava, Czechia, 58601
Not Yet Recruiting
69
Edumed s.r.o.
Náchod, Czechia, 54701
Not Yet Recruiting
70
PreventaMed s.r.o.
Olomouc, Czechia, 77900
Not Yet Recruiting
71
CCR Ostrava
Ostrava, Czechia, 702 00
Not Yet Recruiting
72
Pratia Pardubice
Pardubice, Czechia, 53002
Not Yet Recruiting
73
Fakultní nemocnice Královské Vinohrady
Prague, Czechia, 100 34
Not Yet Recruiting
74
Synexus/Trialmed Prague
Prague, Czechia, 120 00
Not Yet Recruiting
75
ResTrial s.r.o.
Prague, Czechia, 18100
Not Yet Recruiting
76
CDG Studienambulanz Hartard
Munich, Bavaria, Germany, 80809
Not Yet Recruiting
77
Studienzentrum FMZ Radowsky
Leipzig, Saxony, Germany, 04179
Not Yet Recruiting
78
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
Not Yet Recruiting
79
FutureMeds Berlin
Berlin, Germany, 10629
Not Yet Recruiting
80
Velocity Clinical Research Germany
Berlin, Germany, 10787
Not Yet Recruiting
81
Diabetespraxis Dr. Braun
Berlin, Germany, 13187
Not Yet Recruiting
82
Practice Dr. Kirsch and Colleague, Zentrum fur klinische Forschung
Cologne, Germany, 51069
Not Yet Recruiting
83
Pratia
Dresden, Germany, 1069
Not Yet Recruiting
84
Medizentrum Essen Borbeck
Essen, Germany, 45355
Not Yet Recruiting
85
Praxis am Markt - Dr. Bernd Becker
Essen, Germany, 45355
Not Yet Recruiting
86
Klinische Forschung Hamburg GmbH / Pratia
Hamburg, Germany, 20253
Not Yet Recruiting
87
Diabetes Studienzentrum Wilhelmsburg
Hamburg, Germany, 21109
Not Yet Recruiting
88
Diabeteszentrum Hamburg-West
Hamburg, Germany, 22607
Not Yet Recruiting
89
Praxis Reinfeld Mitte
Holstein, Germany, 23858
Not Yet Recruiting
90
Klinische Forschung Karlsruhe GmbH
Karlsruhe, Germany, 76137
Not Yet Recruiting
91
IDFM GmbH
Münster, Germany, 48145
Not Yet Recruiting
92
Gemeinschaftspraxis Dres. H.Kittner und K.Hartig
Naunhof, Germany, 04683
Not Yet Recruiting
93
FutureMeds Frankfurt/Offenbach
Offenbach, Germany, 63065
Not Yet Recruiting
94
Zentrum für klinische Forschung Allgäu-Oberschwaben
Wangen, Germany, 88239
Not Yet Recruiting
95
Medislim GmbH
Weinheim, Germany, 69469
Not Yet Recruiting
96
Santa Familia PTG Lodz
Lodz, WOJ Lodzkie, Poland, 90-302
Not Yet Recruiting
97
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, Poland, 15-351
Not Yet Recruiting
98
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Poland, 85-231
Not Yet Recruiting
99
Centrum medyczne Pratia Bydgoszcz
Bydgoszcz, Poland, 85-796
Not Yet Recruiting
100
Pratia Chojnice
Chojnice, Poland, 89-600
Not Yet Recruiting
101
Synexus Polska Sp. z o.o., Oddzial w Czestochowie
Częstochowa, Poland, 42-202
Not Yet Recruiting
102
Synexus Polska Sp z o.o.
Gdansk, Poland, 80-382
Not Yet Recruiting
103
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Poland, 80-546
Not Yet Recruiting
104
Centrum Medyczne Pratia Gdynia
Gdynia, Poland, 81-338
Not Yet Recruiting
105
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Poland, 81-537
Not Yet Recruiting
106
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice, Poland, 40-040
Not Yet Recruiting
107
Centrum Medyczne Pratia Katowice
Katowice, Poland, 40-081
Not Yet Recruiting
108
Synexus Polska Sp. z o.o., Oddzial w Lodzi
Lodz, Poland, 90-127
Not Yet Recruiting
109
Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna
Lodz, Poland, 90-338
Not Yet Recruiting
110
Ekamed Sp. z o. o.
Lublin, Poland, 20-718
Not Yet Recruiting
111
FutureMeds Olsztyn
Olsztyn, Poland, 10-165
Not Yet Recruiting
112
Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
Oświęcim, Poland, 32-600
Not Yet Recruiting
113
IRMED
Piotrkow Trybunalski, Poland, 97-300
Not Yet Recruiting
114
Trialmed CRS
Piotrkow Trybunalski, Poland, 97-300
Not Yet Recruiting
115
Synexus Polska Sp. z o.o., Oddział w Poznaniu
Poznan, Poland, 60-702
Not Yet Recruiting
116
Praktyka Lekarska Ewa Krzyzagorska
Poznan, Poland, 61-655
Not Yet Recruiting
117
ETG Siedlce
Siedlce, Poland, 08-110
Not Yet Recruiting
118
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
Tarnów, Poland, 33-100
Not Yet Recruiting
119
Instytut Diabetologii.sp.z.o.o.
Warsaw, Poland, 02-117
Not Yet Recruiting
120
Synexus Polska Sp. z o.o., Oddzial w Warszawie
Warsaw, Poland, 02-672
Not Yet Recruiting
121
Etg Warszawa
Warsaw, Poland, 02-677
Not Yet Recruiting
122
Synexus Polska Sp. z o.o., Oddział we Wrocławiu
Wroclaw, Poland, 50-381
Not Yet Recruiting
123
Minimed S.R.L.
Bacau, Romania, 600274
Not Yet Recruiting
124
Futuremeds S.R.L., Brasov
Brasov, Romania, 500388
Not Yet Recruiting
125
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
Bucharest, Romania, 011053
Not Yet Recruiting
126
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, Romania, 011863
Not Yet Recruiting
127
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Not Yet Recruiting
128
Fundatia Dr Victor Babes
Bucharest, Romania, 30303
Not Yet Recruiting
129
Futuremeds S.R.L., Craiova
Craiova, Romania, 200115
Not Yet Recruiting
130
Futuremeds S.R.L., Galati
Galati, Romania, 800183
Not Yet Recruiting
131
Centru Medical "GRANDMED"
Oradea, Romania, 410032
Not Yet Recruiting
132
Sc Gensan Srl/Policlinica Astra
Sibiu, Romania, 550371
Not Yet Recruiting
133
Centrul Medical Mediab - Mediab Srl
Târgu Mureş, Romania, 540142
Not Yet Recruiting
134
DIABEDA s.r.o.
Bratislava, Slovakia, 831 06
Not Yet Recruiting
135
Medispektrum
Bratislava, Slovakia, 85101
Not Yet Recruiting
136
Poliklinika Váš Lekár
Bratislava - Ružinov, Slovakia, 91109
Not Yet Recruiting
137
Cardio D&R Košice
Košice, Slovakia, 040 22
Not Yet Recruiting
138
Medical group Kosice s.r.o.
Košice, Slovakia, 04001
Not Yet Recruiting
139
Tatratrial s.r.o.
Rožňava, Slovakia, 048 01
Not Yet Recruiting
140
JAL s.r.o.
Trnava, Slovakia, 91701
Not Yet Recruiting
141
Medivasa s.r.o
Žilina, Slovakia, 010 01
Not Yet Recruiting
142
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain, 29010
Not Yet Recruiting
143
Hospital Universitario Torrecárdenas (CPE Bola Azul)
Almería, Spain, 04009
Not Yet Recruiting
144
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
145
Hospital Vithas Sevilla
Castilleja de la Cuesta, Spain, 41950
Not Yet Recruiting
146
Futuremeds Spain Cadiz
Chiclana de la Frontera, Spain, 11139
Not Yet Recruiting
147
Futuremeds Spain Madrid
Madrid, Spain, 28003
Not Yet Recruiting
148
Hospital Universitari Son Espases
Palma de Mallorca, Spain, 07120
Not Yet Recruiting
149
Hospital Virgen del Camino
Sanlúcar de Barrameda, Spain, 11540
Not Yet Recruiting
150
Nuevas Tecnologías en Diabetes y Endocrinología S.L.
Seville, Spain, 41003
Not Yet Recruiting
151
Futuremeds Spain Sevilla
Seville, Spain, 41012
Not Yet Recruiting
152
Ecg Médica S.L.
Valencia, Spain, 46015
Not Yet Recruiting
153
Civia Health Sunderland
Hendon, CITY of Sunderland, United Kingdom, SR1 1PB
Not Yet Recruiting
154
Bodyline Medical Clinic St Helens
St Helens, Liverpool, United Kingdom, WA9 1AF
Not Yet Recruiting
155
FutureMeds Glasgow McCafferty House
Glasgow, Scotland, United Kingdom, G20 7BE
Actively Recruiting
156
Bodyline Medical Clinic Stoke on Trent
Stoke-on-Trent, Staffordshire, United Kingdom, ST1 5TL
Not Yet Recruiting
157
Synexus Glasgow Clinical Research Centre
Bellshill, United Kingdom, ML4 3NJ
Actively Recruiting
158
Synexus Midlands Clinical Research Centre
Birmingham, United Kingdom, B15 2SQ
Not Yet Recruiting
159
FutureMeds Birmingham
Birmingham, United Kingdom, B21 9RY
Actively Recruiting
160
Civia Health_Boots Birmingham
Birmingham, United Kingdom, B4 7TA
Not Yet Recruiting
161
Civia Health_Boots Brighton
Brighton, United Kingdom, BN1 2BE
Not Yet Recruiting
162
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Not Yet Recruiting
163
FutureMeds Liverpool
Bromborough, United Kingdom, CH62 6EE
Actively Recruiting
164
Synexus/Trialmed Cardiff
Cardiff, United Kingdom, CF15 9SS
Not Yet Recruiting
165
Panthera Biopartners Limited - Enfield
Enfield, United Kingdom, EN3 4GS
Actively Recruiting
166
Panthera Biopartners Limited - Glasgow
Glasgow, United Kingdom, G51 4RY
Actively Recruiting
167
Bodyline Medical Clinic Crosby
Liverpool, United Kingdom, L224QQ
Not Yet Recruiting
168
FutureMeds London
London, United Kingdom, NW10 2PB
Actively Recruiting
169
Synexus Manchester Clinical Research Centre
Manchester, United Kingdom, M15 6SE
Actively Recruiting
170
Kiltearn Medical Centre
Nantwich, United Kingdom, CW5 5NX
Not Yet Recruiting
171
FutureMeds Newcastle
Newcastle upon Tyne, United Kingdom, NE6 1SG
Actively Recruiting
172
Danes Camp Medical Centre
Northampton, United Kingdom, NN4 0NY
Not Yet Recruiting
173
Civia Health_Boots Nottingham
Nottingham, United Kingdom, NG1 3QS,
Not Yet Recruiting
174
Bodyline Medical Clinic Warrington Civia Health
Paddington, United Kingdom, WA1 3TZ
Not Yet Recruiting
175
Civia Health_Boots Peterborough
Peterborough, United Kingdom, PE1 1NW
Not Yet Recruiting
176
Panthera Biopartners Limited - Preston
Preston, United Kingdom, PR2 9QB
Not Yet Recruiting
177
Panthera Biopartners Limited - Rochdale
Rochdale, United Kingdom, OL11 4AU
Actively Recruiting
178
Clifton Medical Centre
Rotherham, United Kingdom, S651DA
Not Yet Recruiting
179
Ashfields Primary Care Centre
Sandbach, United Kingdom, CW11 1EQ
Not Yet Recruiting
180
Panthera Biopartners Limited - Sheffield
Sheffield, United Kingdom, S2 5FX
Actively Recruiting
181
Staploe Medical Centre
Soham, United Kingdom, ELY CB75JD
Not Yet Recruiting
182
FutureMeds Teesside
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
183
Panthera Biopartners Limited - York
York, United Kingdom, YO24 4LJ
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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