Trial Outcomes & Findings for A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (NCT NCT04076462)
NCT ID: NCT04076462
Last Updated: 2026-08-20
Results Overview
If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
COMPLETED
PHASE3
72 participants
Week 22 and 24
2026-08-20
Participant Flow
Participant milestones
| Measure |
CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
Placebo
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
24
|
|
Overall Study
Treated
|
47
|
24
|
|
Overall Study
COMPLETED
|
46
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
Placebo
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Overall Study
Consent withdrawn
|
2
|
0
|
Baseline Characteristics
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
Baseline characteristics by cohort
| Measure |
CAM2029
n=48 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 15.1 • n=109 Participants
|
55.3 years
STANDARD_DEVIATION 12.8 • n=133 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
12 Participants
n=109 Participants
|
40 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
12 Participants
n=109 Participants
|
32 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
24 Participants
n=109 Participants
|
69 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: Week 22 and 24Population: Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=48 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24
|
37.5 Percentage of participants
|
72.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 22 and 24Population: Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants"
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=48 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction
|
37.5 Percentage of participants
|
72.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 22 and 24Population: Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=48 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Proportion of Participants With Mean IGF-1 Levels ≤1xULN at Week 22/Week 24 and Mean Growth Hormone (GH) Levels <2.5 µg/L at Week 24
|
37.5 Percentage of participants
|
70.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
For the responder analysis of mean GH \<2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=48 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24
|
83.3 Percentage of participants
|
87.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
For the responder analysis of mean GH \<1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=48 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24
|
37.5 Percentage of participants
|
59.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 to 24Population: Safety analysis set (all participants who received at least one dose of IMP)
A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=47 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
19 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Week 0 to 20 and Week 24Population: Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=35 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention
|
20 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 0 to 24Population: The full analysis set (all participants in the intention-to-treat analysis set who received at least one dose of the randomized IMP). Number of participants analyzed at each time point represents the number of participants in the full analysis set who had data at that time point.
Plasma samples were taken pre-dose on dosing days.
Outcome measures
| Measure |
Placebo
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
CAM2029
n=47 Participants
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Octreotide Plasma Concentrations Over Time
Day 1
|
—
|
0.370 ng/mL
Standard Deviation 0.465
|
|
Octreotide Plasma Concentrations Over Time
Week 4
|
—
|
0.852 ng/mL
Standard Deviation 0.495
|
|
Octreotide Plasma Concentrations Over Time
Week 8
|
—
|
0.975 ng/mL
Standard Deviation 0.547
|
|
Octreotide Plasma Concentrations Over Time
Week 12
|
—
|
1.178 ng/mL
Standard Deviation 0.822
|
|
Octreotide Plasma Concentrations Over Time
Week 16
|
—
|
1.005 ng/mL
Standard Deviation 0.635
|
|
Octreotide Plasma Concentrations Over Time
Week 20
|
—
|
1.104 ng/mL
Standard Deviation 0.877
|
|
Octreotide Plasma Concentrations Over Time
Week 22
|
—
|
2.226 ng/mL
Standard Deviation 1.241
|
|
Octreotide Plasma Concentrations Over Time
Week 24
|
—
|
1.049 ng/mL
Standard Deviation 0.970
|
Adverse Events
CAM2029
Placebo
Serious adverse events
| Measure |
CAM2029
n=47 participants at risk
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
Placebo
n=24 participants at risk
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Infections and infestations
Covid-19
|
4.3%
2/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
0.00%
0/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Infections and infestations
Covid-19 pneumonia
|
2.1%
1/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
0.00%
0/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Infections and infestations
Influenza
|
2.1%
1/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
0.00%
0/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
4.2%
1/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
4.2%
1/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
Other adverse events
| Measure |
CAM2029
n=47 participants at risk
CAM2029 (octreotide subcutaneous depot) 20 mg/1.0mL for 20 mg dose, subcutaneous injection once monthly, six months treatment.
|
Placebo
n=24 participants at risk
Placebo 1.0 mL, subcutaneous injection once monthly, six months treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.4%
3/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
0.00%
0/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site mass
|
6.4%
3/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
20.8%
5/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Fatigue
|
6.4%
3/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
4.2%
1/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site erythema
|
25.5%
12/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
20.8%
5/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site swelling
|
14.9%
7/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
8.3%
2/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site pruritus
|
14.9%
7/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
4.2%
1/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site induration
|
8.5%
4/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
12.5%
3/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site pain
|
8.5%
4/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
12.5%
3/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site nodule
|
8.5%
4/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
4.2%
1/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
General disorders
Injection site rash
|
0.00%
0/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
8.3%
2/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.0%
8/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
8.3%
2/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Infections and infestations
Covid-19
|
4.3%
2/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
12.5%
3/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.5%
4/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
0.00%
0/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
0.00%
0/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
12.5%
3/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/47 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
8.3%
2/24 • 24 weeks
Safety analysis set (all participants who received at least one dose of IMP)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place