A Phase 3 interventional study of CAM2029 (octreotide subcutaneous depot) and Matching placebo in Acromegaly, sponsored by Camurus AB. Completed at 63 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Camurus AB · Phase 3, Interventional, and Treatment
The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 72 is above the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →Camurus AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
Drug: CAM2029 (octreotide subcutaneous depot)
Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.
Drug: Matching placebo
Drug pages: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Also known as: CAM2029
Matching placebo for CAM2029
Also known as: placebo
Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24
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".
Time frame: Week 22 and 24
Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction
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"
Time frame: Week 22 and 24
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
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".
Time frame: Week 22 and 24
Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24
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".
Time frame: Week 24
Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24
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".
Time frame: Week 24
Number of Participants With Treatment Emergent Adverse Events
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.
Time frame: Week 0 to 24
Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention
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.
Time frame: Week 0 to 20 and Week 24
Octreotide Plasma Concentrations Over Time
Plasma samples were taken pre-dose on dosing days.
Time frame: Week 0 to 24
| Milestone | CAM2029 | Placebo |
|---|---|---|
| Started | 48 | 24 |
| Treated | 47 | 24 |
| Completed | 46 | 24 |
| Not completed | 2 | 0 |
| Withdrew: Consent withdrawn | 2 | 0 |
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".
| Percentage of participants | CAM2029 | Placebo |
|---|---|---|
| Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24 | 72.2 | 37.5 |
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"
| Percentage of participants | CAM2029 | Placebo |
|---|---|---|
| Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction | 72.2 | 37.5 |
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".
| Percentage of participants | CAM2029 | Placebo |
|---|---|---|
| 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 | 70.0 | 37.5 |
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".
| Percentage of participants | CAM2029 | Placebo |
|---|---|---|
| Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24 | 87.5 | 83.3 |
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".
| Percentage of participants | CAM2029 | Placebo |
|---|---|---|
| Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24 | 59.9 | 37.5 |
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.
| Participants | CAM2029 | Placebo |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 37 | 19 |
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.
| Participants | CAM2029 | Placebo |
|---|---|---|
| Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention | 32 | 20 |
Plasma samples were taken pre-dose on dosing days.
| ng/mL | CAM2029 |
|---|---|
| Day 1 | 0.370 ± 0.465 |
| Week 4 | 0.852 ± 0.495 |
| Week 8 | 0.975 ± 0.547 |
| Week 12 | 1.178 ± 0.822 |
| Week 16 | 1.005 ± 0.635 |
| Week 20 | 1.104 ± 0.877 |
| Week 22 | 2.226 ± 1.241 |
| Week 24 | 1.049 ± 0.970 |
Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAM2029 | 0/47 (0%) | 4/47 (8.5%) | 36/47 (76.6%) |
| Placebo | 0/24 (0%) | 2/24 (8.3%) | 19/24 (79.2%) |
| Event | CAM2029 | Placebo |
|---|---|---|
| Covid-19Infections and infestations | 2/47 | 0/24 |
| Gastritis erosiveGastrointestinal disorders | 0/47 | 1/24 |
| CholecystitisHepatobiliary disorders | 0/47 | 1/24 |
| Covid-19 pneumoniaInfections and infestations | 1/47 | 0/24 |
| InfluenzaInfections and infestations | 1/47 | 0/24 |
| Event | CAM2029 | Placebo |
|---|---|---|
| Injection site erythemaGeneral disorders | 12/47 | 5/24 |
| Injection site massGeneral disorders | 3/47 | 5/24 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/47 | 2/24 |
| Injection site swellingGeneral disorders | 7/47 | 2/24 |
| Injection site pruritusGeneral disorders | 7/47 | 1/24 |
| AnaemiaBlood and lymphatic system disorders | 1/47 | 3/24 |
| Injection site indurationGeneral disorders | 4/47 | 3/24 |
| Injection site painGeneral disorders | 4/47 | 3/24 |
| Covid-19Infections and infestations | 2/47 | 3/24 |
| Injection site noduleGeneral disorders | 4/47 | 1/24 |
Intention-to-treat analysis set (all participants who were randomized to a treatment arm)
| Age, Continuous(years) | CAM2029 | Placebo | Total |
|---|---|---|---|
| Mean | 57.0 ± 11.2 | 52.0 ± 15.1 | 55.3 ± 12.8 |
| Sex: Female, Male(Participants) | CAM2029 | Placebo | Total |
|---|---|---|---|
| Female | 28 | 12 | 40 |
| Male | 20 | 12 | 32 |
| Race (NIH/OMB)(Participants) | CAM2029 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 45 | 24 | 69 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029
Camurus AB